Ovarian CancerPhase 1/2NCT04939701
Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants
A Phase 1/2 study testing ASP0739 in people with Ovarian Cancer and NSCLC, run by Astellas Pharma Global Development, Inc. at 6 sites in United States.
Trial summary
The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab. This study also evaluated the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, NSCLC, ESCC
- What is being tested?
- ASP0739
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Dec 2021to 1 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1 Dose Escalation only:
- Participant has relapsed/refractory (R/R) solid tumor known to express NY-ESO-1 after completing available Standard of Care (SOC) therapy or is not a candidate for SOC therapy. NY-ESO-1 expression status is not required for participant entry.
- Safety Lead-in, Phase 2 Single agent and Combination Therapy only:
- Participant has relapsed/refractory (R/R) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) disease after undergoing available SOC treatment or is not a candidate for SOC therapy (must have previously received either an anthracycline or ifosfamide containing regimen or another systemic regimen, if not a candidate for either agent).
- Participant has not received prior checkpoint inhibitor therapy (i.e., Programmed Cell Death Protein 1 [PD-1]/Programmed Death Ligand 1 [PD-L1] treatment naive)
- SS: confirmation by the presence of a translocation between SYT on the X chromosome and SSX1, SSX2, or SSX4 on chromosome 18 (may be presented in the pathology report as t [X;18]).
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- MRCL: confirmation by the presence of the reciprocal chromosomal translocation t (12;16) (q13;p11) or t(12;22)(q13;q12).
- Participant has R/R ovarian cancer that is:
- platinum resistant OR platinum-sensitive, but the participant is not a candidate for platinum or other SOC therapy.
- Participant has not received prior checkpoint inhibitor therapy (i.e., naive PD-1/PD-L1 treatment participants).
- Participant has R/R solid tumor (melanoma, non-small cell lung cancer [NSCLC]-adenocarcinoma and squamous cell, or esophageal squamous cell carcinoma [ESCC]) after available SOC treatment or is not a candidate for SOC therapy (single-agent only).
- Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides prior to IP administration.
- Participant in phase 2 consents to provide tumor specimen obtained within 56 days prior to first dose of study treatment, as tissue block or unstained serial slides.
- Participant in phase 2 consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
- Participant with life expectancy of >= 12 weeks at the time of screening.
- Participant must meet criteria for clinical laboratory tests during screening period.
- A female participant is eligible to participate if she is not pregnant and at least one of the following conditions apply:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final investigational product (IP) administration.
- Female participant must not be breastfeeding at screening or during the study period and for 6 months after the final IP administration.
- Female participant must not donate ova at screening and throughout the study period and for 6 months after the final IP administration.
- A male participant with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 6 months after the final IP administration.
- Male participant must not donate sperm starting at screening and throughout the study period and for 6 months after the final IP administration.
- Participant agrees not to participate in another interventional study while on treatment.
- Participant measurable disease according to RECIST 1.1. For participant with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Who cannot join
- Participant has persistent non-hematological toxicities of >= grade 2 (National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0), with symptoms and objective findings from treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation or surgery).
- Participant has received any of the following therapies (for inclusion in the study, all abnormalities must have returned to <= grade 1):
- Systemic immunomodulators (checkpoint inhibitors)-except the dose escalation phase and the NY-ESO-1 solid tumor (melanoma, NSCLC-adenocarcinoma and squamous cell and ESCC) cohorts in the dose expansion phase of monotherapy, which may have received prior checkpoint inhibitor therapy
- Immunosuppressive drugs including steroids <= 14 days prior to treatment
- Cytotoxic agents <= 14 days prior to treatment
- Investigational agent <= 21 days prior to treatment or 5 half-lives, whichever is shorter
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- Radiation therapy <= 21 days prior to treatment
- Participant has clinically active or untreated nervous system metastases. Participants with previously treated Central Nervous System (CNS) metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
- Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
- Participant was discontinued from prior immunomodulatory therapy due to a grade >= 3 toxicity that was mechanistically related (e.g., immune related) to the agent.
- Participant has known history of serious hypersensitivity reaction to a known ingredient of ASP0739 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.
- Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years prior to screening visit, except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.
- Participant has received a prior allogeneic bone marrow or solid organ transplant.
- Participant has an active uncontrolled infection within 14 days of treatment.
- Participant is known to have human immunodeficiency virus infection.
- Participant has active hepatitis B or C or other active hepatic disorder or participant is on hepatitis treatment. Hepatitis C RNA testing is not required in participants with negative hepatitis C antibody testing.
- Participant has any condition which makes the participant unsuitable for study participation.
- Participant has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.
- Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Participant is expected to require another form of anti-cancer therapy while on study treatment.
- Participant has a known or suspected hypersensitivity to bovine-derived protein or has suspected hypersensitivity to any ingredients of ASP0739.
- Additional Exclusion Criteria for Participants in Combination Therapy Cohorts
- Participants with a history of myocarditis or congestive heart failure (as defined by New York Heart Associated Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry.
- Participants with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
- Participants with baseline pulse oximetry < 92% "on Room air."
- Participants must not have known microsatellite instability-high or deficient MisMatch Repair.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
The University of Chicago Medicine
Chicago, Illinois, 60637
City of Hope
Duarte, California, 91010
University of Miami
Miami, Florida, 33136
NYU Perlmutter Cancer Center
New York, New York, 10016
Brown University
Providence, Rhode Island, 02903
About this study
Official title: A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express NY-ESO-1
The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab.
This study also evaluated the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.
Read the detailed description
The study comprised of 2 phases. Phase 1 (dose escalation) included participants with solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1). Phase 2 (ASP0739 as single agent and in combination with pembrolizumab) included participants with relapsed/refractory Synovial Sarcoma (SS), myxoid/round cell liposarcoma (MRCL), and ovarian cancer who had not responded to Standard of Care (SOC) or were ineligible for standard therapy. Phase 2 single agent also included a cohort of participants with select solid tumors known to express NY-ESO-1 (melanoma, Non Small Cell Lung Cancer-adenocarcinoma [NSCLC], squamous cell and esophageal squamous cell carcinoma [ESCC]). Japanese participants were only enrolled into the monotherapy arm of the dose expansion cohort.
- Conditions
- Ovarian Cancer, NSCLC, ESCC, Solid Tumors
- Being tested
- ASP0739
- Keywords
- NY-ESO-1, ASP0739, Solid Tumor, NSCLC, ESCC, MRCL, Ovarian Cancer, R/R SS
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP0739Drug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation (Phase 1): ASP0739 1x10^7 cells/mL | Experimental | Participants with Relapsed/Refractory (R/R) solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1) received intravenous (IV) infusion of ASP0739 (human embryonic kidney cell [HEK293] transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^7 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a partial response (PR) or stable disease (SD) (1 cycle= 28 days). . Receives: Drug: ASP0739 |
| Dose Escalation (Phase 1): ASP0739 1x10^8 cells/mL | Experimental | Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). Receives: Drug: ASP0739 |
| Dose Expansion (Phase 2): ASP0739 1x10^8 cells/mL | Experimental | Participants with synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCL), ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, non-small cell lung cancer [NSCLC] adenocarcinoma and squamous cell and esophageal squamous cell carcinoma [ESCC]) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). Receives: Drug: ASP0739 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as:
- Grade (GR) ≥2 autoimmune reaction
- GR 3 Immune related AEs (irAEs) that did not resolve to GR ≤1 in 3 to 5 days, febrile neutropenia with or without infection, thrombocytopenia with bleeding requiring transfusion, anemia requiring transfusion
- GR 4 irAEs, neutropenia, thrombocytopenia, anemia
- GR ≥3 non-hematological AE that did not resolve to GR ≤2 within 72 hours of onset, liver function test abnormality lasting ≥7 days Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 × upper limit of normal (ULN; GR≥3) without liver metastases and 8 × ULN in participants with liver metastases, AST or ALT >3 × ULN and total bilirubin (TBL) >2 × ULN (in participants with, Gilbert syndrome: AST or ALT >3 × ULN and direct bilirubin >1.5) (confirmed Hy's Law)
- GR 5 toxicity, Prolonged delay (>2 weeks) in initiating cycle 2 due to treatment-related toxicity.
Measured: Cycle 1 Day 1 (C1D1) up to C1D28
Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose.
Measured: From first dose up to 198 days
Number of Participants With ECOG Performance Status at C1D2
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C1D2
Number of Participants With ECOG Performance Status at C1D8
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C1D8
Number of Participants With ECOG Performance Status at CID15
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At CID15
Number of Participants With ECOG Performance Status at CID22
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At CID22
Number of Participants With ECOG Performance Status at C2D1
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C2D1
Number of Participants With ECOG Performance Status at C2D2
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C2D2
Number of Participants With ECOG Performance Status at C2D8
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C2D8
Number of Participants With ECOG Performance Status at C2D15
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C2D15
Number of Participants With ECOG Performance Status at C2D22
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C2D22
Number of Participants With ECOG Performance Status at C3D1
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C3D1
Number of Participants With ECOG Performance Status at C3D8
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C3D8
Number of Participants With ECOG Performance Status at C3D15
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C3D15
Number of Participants With ECOG Performance Status at C3D22
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C3D22
Number of Participants With ECOG Performance Status at C4D1
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C4D1
Number of Participants With ECOG Performance Status at C4D8
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C4D8
Number of Participants With ECOG Performance Status at C4D15
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C4D15
Number of Participants With ECOG Performance Status at C4D22
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C4D22
Number of Participants With ECOG Performance Status at C5D1
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C5D1
Number of Participants With ECOG Performance Status at C5D15
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C5D15
Number of Participants With ECOG Performance Status at C6D1
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C6D1
Number of Participants With ECOG Performance Status at C6D15
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At C6D15
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead. EOT visit was 7 days after last dose.
Measured: At EOT visit (day 175)
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At 30 days safety follow up (day 198)
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At 60 days safety follow up (day 228)
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days
The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
- - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
- - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
- - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
- -Dead.
Measured: At 90 days safety follow up (day 258)
Recommended Phase 2 Dose (RP2D)
The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies.
Measured: C1D1 up to C1D28
Objective Response Rate Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR) by Independent Central Review
iORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (iCR) or partial response (iPR) per iRECIST. iORR assessments included:
- iORR with confirmed response
- iORR with unconfirmed response iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: From first dose up to 525 days
Secondary outcomes (10)
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (ORR) by Investigator Assessment
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as CR or PR per RECIST v1.1. ORR assessment included:
ORR with confirmed response ORR with unconfirmed response
Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.
CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: From first dose up to 525 days
Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment
iDCR was defined as the percentage of participants for each dose level whose best overall response is rated as confirmed and unconfirmed iCR, iPR or stable disease (iSD) per iRECIST.
iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. SD was defined as neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for progressive disease.
Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.
Measured: From first dose up to 525 days
Disease Control Rate Per RECIST v1.1 (DCR) by Investigator Assessment
DCR is defined as the percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1.CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Measured: From first dose up to 525 days
Progression-Free Survival Per iRECIST (iPFS) by Independent Central Review
iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by independent central review.
Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Measured: From first dose up to 525 days
iPFS Per iRECIST by Investigator Assessment
iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by investigator assessment.
Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Measured: From first dose up to 525 days
Progression-Free Survival Per RECIST v1.1 (PFS) by Investigator Assessment
PFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per RECIST v1.1 by investigator assessment.Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started
Measured: From first dose up to 525 days
Duration of Overall Survival (OS)
OS is defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1).
Measured: From first dose up to 525 days
Duration of Response Per iRECIST (iDOR)
iDOR as per iRECIST was defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of radiographical progression or date of censoring. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: From first response up to 525 days
Duration of Response Per RECIST (DOR) v1.1
DOR as per RECIST 1.1 was defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring.
CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Measured: From first response up to 525 days
ORR Per iRECIST (iORR) by Investigator Assessment
iORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per iRECIST. iORR assessments included:
- iORR with confirmed response
- iORR with unconfirmed response iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.
Measured: From first dose up to 525 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start23 Dec 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: The comprehensive assessment of other studies indicated the lack of significant monotherapy activity, therefore, team decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939701
- Sponsor's protocol ID
- 0739-CL-0101
- Status last verified
- Nov 2024
- First submitted
- 18 Jun 2021
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express NY-ESO-1
- ClinicalTrials.gov ID
- NCT04939701
- Acronym / sponsor ID
- 0739-CL-0101
- Conditions
- Ovarian Cancer, NSCLC, ESCC, Solid Tumors
- Keywords
- NY-ESO-1, ASP0739, Solid Tumor, NSCLC, ESCC, MRCL, Ovarian Cancer, R/R SS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The comprehensive assessment of other studies indicated the lack of significant monotherapy activity, therefore, team decided to terminate the study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab.
This study also evaluated the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.
Detailed description
The study comprised of 2 phases. Phase 1 (dose escalation) included participants with solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1). Phase 2 (ASP0739 as single agent and in combination with pembrolizumab) included participants with relapsed/refractory Synovial Sarcoma (SS), myxoid/round cell liposarcoma (MRCL), and ovarian cancer who had not responded to Standard of Care (SOC) or were ineligible for standard therapy. Phase 2 single agent also included a cohort of participants with select solid tumors known to express NY-ESO-1 (melanoma, Non Small Cell Lung Cancer-adenocarcinoma [NSCLC], squamous cell and esophageal squamous cell carcinoma [ESCC]). Japanese participants were only enrolled into the monotherapy arm of the dose expansion cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation (Phase 1): ASP0739 1x10^7 cells/mL | Experimental | Drug: ASP0739Participants with Relapsed/Refractory (R/R) solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1) received intravenous (IV) infusion of ASP0739 (human embryonic kidney cell [HEK293] transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^7 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a partial response (PR) or stable disease (SD) (1 cycle= 28 days). . |
| Dose Escalation (Phase 1): ASP0739 1x10^8 cells/mL | Experimental | Drug: ASP0739Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
| Dose Expansion (Phase 2): ASP0739 1x10^8 cells/mL | Experimental | Drug: ASP0739Participants with synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCL), ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, non-small cell lung cancer [NSCLC] adenocarcinoma and squamous cell and esophageal squamous cell carcinoma [ESCC]) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Participant has relapsed/refractory (R/R) solid tumor known to express NY-ESO-1 after completing available Standard of Care (SOC) therapy or is not a candidate for SOC therapy. NY-ESO-1 expression status is not required for participant entry.
- Participant has relapsed/refractory (R/R) synovial sarcoma (SS) or myxoid/round cell liposarcoma (MRCL) disease after undergoing available SOC treatment or is not a candidate for SOC therapy (must have previously received either an anthracycline or ifosfamide containing regimen or another systemic regimen, if not a candidate for either agent).
- Participant has R/R ovarian cancer that is:
- Participant has R/R solid tumor (melanoma, non-small cell lung cancer [NSCLC]-adenocarcinoma and squamous cell, or esophageal squamous cell carcinoma [ESCC]) after available SOC treatment or is not a candidate for SOC therapy (single-agent only).
- Participant consents to provide an archival tumor specimen in a tissue block or unstained serial slides prior to IP administration.
Key exclusion criteria (26 listed)
- Participant has persistent non-hematological toxicities of >= grade 2 (National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0), with symptoms and objective findings from treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation or surgery).
- Participant has received any of the following therapies (for inclusion in the study, all abnormalities must have returned to <= grade 1):
- Participant has clinically active or untreated nervous system metastases. Participants with previously treated Central Nervous System (CNS) metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
- Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
- Participant was discontinued from prior immunomodulatory therapy due to a grade >= 3 toxicity that was mechanistically related (e.g., immune related) to the agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP0739Intravenous (IV) | Drug | Dose Escalation (Phase 1): ASP0739 1x10^7 cells/mL, Dose Escalation (Phase 1): ASP0739 1x10^8 cells/mL, Dose Expansion (Phase 2): ASP0739 1x10^8 cells/mL |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1 (C1D1) up to C1D28
DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as: * Grade (GR) ≥2 autoimmune reaction * GR 3 Immune related AEs (irAEs) that did not resolve to GR ≤1 in 3 to 5 days, febrile neutropenia with or without infection, thrombocytopenia with bleeding requiring transfusion, anemia requiring transfusion * GR 4 irAEs, neutropenia, thrombocytopenia, anemia * GR ≥3 non-hematological AE that did not resolve to GR ≤2 within 72 hours of onset, liver function test abnormality lasting ≥7 days Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 × upper limit of normal (ULN; GR≥3) without liver metastases and 8 × ULN in participants with liver metastases, AST or ALT >3 × ULN and total bilirubin (TBL) >2 × ULN (in participants with, Gilbert syndrome: AST or ALT >3 × ULN and direct bilirubin >1.5) (confirmed Hy's Law) * GR 5 toxicity, Prolonged delay (>2 weeks) in initiating cycle 2 due to treatment-related toxicity.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs)
Time frame: From first dose up to 198 days
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose.
Number of Participants With ECOG Performance Status at C1D2
Time frame: At C1D2
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C1D8
Time frame: At C1D8
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at CID15
Time frame: At CID15
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at CID22
Time frame: At CID22
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C2D1
Time frame: At C2D1
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C2D2
Time frame: At C2D2
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C2D8
Time frame: At C2D8
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C2D15
Time frame: At C2D15
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C2D22
Time frame: At C2D22
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C3D1
Time frame: At C3D1
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C3D8
Time frame: At C3D8
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C3D15
Time frame: At C3D15
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C3D22
Time frame: At C3D22
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C4D1
Time frame: At C4D1
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C4D8
Time frame: At C4D8
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C4D15
Time frame: At C4D15
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C4D22
Time frame: At C4D22
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C5D1
Time frame: At C5D1
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C5D15
Time frame: At C5D15
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C6D1
Time frame: At C6D1
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at C6D15
Time frame: At C6D15
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at End of Treatment (EOT) Visit
Time frame: At EOT visit (day 175)
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. EOT visit was 7 days after last dose.
Number of Participants With ECOG Performance Status at Safety Follow up 30 Days
Time frame: At 30 days safety follow up (day 198)
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at Safety Follow up 60 Days
Time frame: At 60 days safety follow up (day 228)
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Number of Participants With ECOG Performance Status at Safety Follow up 90 Days
Time frame: At 90 days safety follow up (day 258)
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead.
Recommended Phase 2 Dose (RP2D)
Time frame: C1D1 up to C1D28
The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies.
Objective Response Rate Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR) by Independent Central Review
Time frame: From first dose up to 525 days
iORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (iCR) or partial response (iPR) per iRECIST. iORR assessments included: * iORR with confirmed response * iORR with unconfirmed response iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
10 secondary outcomes
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (ORR) by Investigator Assessment
Time frame: From first dose up to 525 days
Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment
Time frame: From first dose up to 525 days
Disease Control Rate Per RECIST v1.1 (DCR) by Investigator Assessment
Time frame: From first dose up to 525 days
Progression-Free Survival Per iRECIST (iPFS) by Independent Central Review
Time frame: From first dose up to 525 days
iPFS Per iRECIST by Investigator Assessment
Time frame: From first dose up to 525 days
Progression-Free Survival Per RECIST v1.1 (PFS) by Investigator Assessment
Time frame: From first dose up to 525 days
Duration of Overall Survival (OS)
Time frame: From first dose up to 525 days
Duration of Response Per iRECIST (iDOR)
Time frame: From first response up to 525 days
Duration of Response Per RECIST (DOR) v1.1
Time frame: From first response up to 525 days
ORR Per iRECIST (iORR) by Investigator Assessment
Time frame: From first dose up to 525 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ASP0739 in people with Ovarian Cancer and NSCLC, run by Astellas Pharma Global Development, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 Day 1 (C1D1) up to C1D28). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.