Metastatic CancerPhase 1NCT03954067
A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors
A Phase 1 study testing ASP9801 and Pembrolizumab in people with Metastatic Cancer and Solid Tumors, run by Astellas Pharma Global Development, Inc. at 17 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Solid Tumors, Advanced Cancer
- What is being tested?
- ASP9801 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 17 sitesUnited States
- Study dates
- 3 Sep 2019to 19 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic solid tumor(s).
- Subject has measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
- Subject has had disease progression after, been intolerant to, or has refused all available therapies that are known to confer clinical benefit. Note: There is no limit to the number of prior treatment regimens.
- Subject has a predicted life expectancy ≥ 12 weeks.
- Subject has at least 2 sites of disease suitable for biopsy and is willing and able to undergo required tumor biopsies according to the treating institution's guidelines at screening and during study treatment.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- A female subject is eligible to participate if she is not pregnant as documented by negative pregnancy test within 72 hours prior to treatment and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 180 days after the final study investigational product (IP) administration.
- Female subject must agree not to breastfeed starting at screening, and throughout the study period and 180 days after the final study IP administration.
- Female subject must not donate ova starting at screening, and throughout the study period and for 180 days after the final study IP administration.
- Male subject must agree to remain abstinent or use a condom throughout the study period and for 180 days after the final study IP administration.
- Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 180 days after the final study IP administration.
- Male subject must not donate sperm during the treatment period and for at least 180 days after the final study IP administration.
- Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
- Subject agrees not to participate in another interventional study while receiving study IP.
- Subject has the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subject has ongoing toxicity ≥ National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant.
- Subject who has had major surgery ≤ 4 weeks of screening. Subjects must have recovered from prior procedures and/or any complications from surgery prior to starting study treatment.
- Subject is concurrently participating in another interventional study or has received an investigational product ≤ 30 days or 5 half-lives whichever is shorter, prior to first IP administration.
- Subject with symptomatic or untreated central nervous system (CNS) metastases or leptomeningeal disease. Subjects with treated symptomatic brain metastases should be neurologically stable (without evidence of progression by imaging for at least 4 weeks prior to screening and any neurologic symptoms have returned to baseline) and off steroids for at least 2 weeks prior to first IP administration. Subjects with carcinomatous meningitis are excluded regardless of clinical stability.
- Subject with active or prior autoimmune or inflammatory disorders requiring systemic therapy within past 2 years (including inflammatory skin conditions or severe eczema, inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
- The following are exceptions to this criterion:
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- Subject with vitiligo or alopecia
- Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Subject with another malignancy that currently requires treatment.
- Subject with only tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for adverse events (AEs) or otherwise not considered appropriate for IT injection. Subjects with such tumors that have other injectable tumors would be eligible.
- Subject with inadequate organ and marrow functions meeting any of the below criteria:
- Leukocytes < 3000/μL
- Absolute neutrophil count < 1500/μL
- Platelets < 100,000/μL
- Hemoglobin (Hgb) < 9 g/dL (Criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Subjects can be on stable dose of erythropoietin [≥ approximately 3 months])
- International normalized ratio (INR) > 1.5 × ULN and/or activated partial thromboplastin time (aPTT) > 1.5 × institutional normal limits, except for subjects in Group B (Visceral Lesions) escalation and expansion groups where INR and aPTT must be normal
- Total Bilirubin (TBL) > 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL > 3.0 × institutional normal limits or direct bilirubin > 1.5 × institutional normal limits)
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) > 2.5 × institutional normal limits. Subjects with tumors in the liver AST and ALT > 5 × institutional normal limits.
- Albumin < 3.0 g/dL
- Creatinine > 1.5 × institutional normal limits
- Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study IP. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Subject has an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements or a condition that could invalidate communication with the investigator.
- Subject is positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core immunoglobulin or immunoglobulin G (IgG) antibody or hepatitis C (IgG or ribonucleic acid (RNA) test) indicating acute or chronic infection.
- Subject has a history of moderate to severe ascites, clinically significant and/or rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy or pericardial and/or pleural effusions related to liver insufficiency within 6 months of screening. Mild ascites that does not preclude safe IT injection of ASP9801 is allowed.
- Subject has a clinically significant abnormal electrocardiogram (ECG) at screening.
- Subject has symptomatic cardiovascular disease within the preceding 12 months unless cardiology consultation and clearance has been obtained for study participation, including but not limited to the following: significant coronary artery disease (e.g., requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris < 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia or congestive heart failure (New York Heart Association grade ≥ 2).
- Subject has medical conditions that predispose the subject to untoward medical risk in the event of volume loading (e.g., intravenous fluid bolus infusion), tachycardia or hypotension during or following treatment with ASP9801.
- Subject has a known or suspected hypersensitivity to ASP9801 or any components of the formulation used, including prior adverse reaction to vaccinia (e.g., as smallpox vaccine).
- Subject has had previous exposure with ASP9801.
- Subject has an active infection requiring systemic therapy.
- Subject with known history of active Bacillus Tuberculosis.
- Subject has received prior therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4, OX 40, CD137) and was discontinued from that treatment due to an immune-related adverse event.
- Subject has received prior radiation therapy within 2 weeks of start of study treatment. Subject must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
- Subject has received a live vaccine within 30 days prior to the first dose of study drug.
- Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guérin and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Subject has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients, or history of ≥ grade 2 infusion reactions that were not prevented by adequate premedication.
- Subject has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Subject has had an allogeneic tissue/solid organ transplant.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Roswell Park Cancer Institute - Medical Oncology
Buffalo, New York, 14263
UVA Cancer Center
Charlottesville, Virginia, 22903
The University of Chicago Medical Center
Chicago, Illinois, 60637
Mary Crowley Cancer Research Center
Dallas, Texas, 75251
Henry Ford Hospital
Detroit, Michigan, 48202
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Norton Cancer Institute
Louisville, Kentucky, 40241
University of Minnesota
Minneapolis, Minnesota, 55455
Nebraska Methodist Hospital
Omaha, Nebraska, 68130
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260
VCU Massey Cancer Center
Richmond, Virginia, 23298
University of Arizona - Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced/Metastatic Solid Tumors
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.
Read the detailed description
The study consists of two parts: dose escalation and recommended phase 2 dose expansion. Each part of the study will include two separate groups of participants. Group A will include participants who will have cutaneous/subcutaneous tumors injected, and group B will include participants who will have visceral tumors injected. In dose escalation part only ASP9801 will be assessed. In dose expansion part along with ASP9801 (monotherapy) ASP9801 + Pembrolizumab (combination therapy) will be assessed. The study will consist of the following periods: screening, initial treatment period (two 28 day cycles), optional extended treatment period (continued 28 day cycles) and a follow up period (safety and survival follow up).
- Conditions
- Metastatic Cancer, Solid Tumors, Advanced Cancer
- Being tested
- ASP9801, Pembrolizumab
- Keywords
- immunotherapy, vaccinia virus, visceral lesions, cutaneous lesions, intratumoral injection, ASP9801, subcutaneous lesions, oncolytic virus
- Medical subject headings
- Neoplasm Metastasis, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP9801Biological
Administered by intratumoral injection
PembrolizumabCombination product
Also called KEYTRUDA®
Administered by Intravenous Infusion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation - cutaneous or subcutaneous lesions | Experimental | Participants will receive ASP9801 (1x10^7 pfu/mL) on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Biological: ASP9801 |
| Dose Escalation - visceral lesions | Experimental | Participants will receive ASP9801 (1x10^8 pfu/mL) on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Biological: ASP9801 |
| Dose Expansion (Monotherapy) - cutaneous or subcutaneous lesions | Experimental | Participants will receive ASP9801 (1x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Biological: ASP9801 |
| Dose Expansion (Monotherapy) - visceral lesions | Experimental | Participants will receive ASP9801 (5x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Biological: ASP9801 |
| Dose Expansion (Monotherapy Induction) - cutaneous or subcutaneous lesions | Experimental | Participants will receive ASP9801 (5x10^8 pfu/mL) on days 1, 8, 15 and 22 of the first 28 day cycle. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Biological: ASP9801 |
| Dose Expansion (Combination Therapy) - cutaneous or subcutaneous lesions | Experimental | Participants will receive ASP9801 (1x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Combination Product: Pembrolizumab |
| Dose Expansion (Combination Induction Therapy) - cutaneous or subcutaneous lesions | Experimental | Participants will receive ASP9801 (5x10^8 pfu/mL) on days 1, 8, 15 and 22 of first 28 day cycle at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Combination Product: Pembrolizumab |
| Dose Expansion (Combination Therapy) - visceral lesions | Experimental | Participants will receive ASP9801 (5x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. Receives: Combination Product: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT) - dose escalation part
Incidence of dose limiting toxicities
Measured: Up to 28 days
Safety and tolerability assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Measured: Up to 12 months
Number of participants with laboratory value abnormalities and/or adverse events
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 12 months
Number of participants with vital sign abnormalities and /or adverse events
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 12 months
Safety assessed by 12- lead electrocardiograms (ECGs) adverse events
12-lead ECGs will be read and assessed locally. Any clinically significant adverse changes on the ECG will be reported as Adverse Events.
Measured: Up to 12 months
Secondary outcomes (8)
Percent change from baseline in antitumor activity of ASP9801
Percent change from baseline in sum of diameters of injected tumors per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and immune modified response evaluation criteria in solid tumors (imRECIST)
Measured: Up to 12 months
Objective Response Rate per imRECIST
Partial Response (PR) + Complete Response (CR) per imRECIST
Measured: Up to 12 months
ASP9801 viral DNA in blood
Viral DNA load will be summarized by cohort using descriptive statistics.
Measured: Up to 12 months
Viral shedding of ASP9801 in saliva
Viral DNA will be analyzed by quantitative polymerase chain reaction (qPCR).
Measured: Up to 12 months
Viral shedding of ASP9801 in urine
Viral DNA will be analyzed by qPCR.
Measured: Up to 12 months
Viral shedding of ASP9801 in skin (cutaneous/subcutaneous only)
Viral DNA will be analyzed by qPCR.
Measured: Up to 12 months
Objective Response Rate per Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1
Partial Response (PR) + Complete Response (CR) per RECIST 1.1.
Measured: Up to 12 months
Change in Programmed Cell Death Ligand 1 (PD-L1) Expression in Tumor
Changes in level of PDL1 expression in tumors will be reported.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start3 Sep 2019
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954067
- Sponsor's protocol ID
- 9801-CL-0101
- Other IDs
- KEYNOTE-B26, MK-3475-B26
- Status last verified
- Apr 2025
- First submitted
- 14 May 2019
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03954067
- Acronym / sponsor ID
- 9801-CL-0101
- Conditions
- Metastatic Cancer, Solid Tumors, Advanced Cancer
- Keywords
- immunotherapy, vaccinia virus, visceral lesions, cutaneous lesions, intratumoral injection, ASP9801, subcutaneous lesions, oncolytic virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
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 is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.
Detailed description
The study consists of two parts: dose escalation and recommended phase 2 dose expansion. Each part of the study will include two separate groups of participants. Group A will include participants who will have cutaneous/subcutaneous tumors injected, and group B will include participants who will have visceral tumors injected. In dose escalation part only ASP9801 will be assessed. In dose expansion part along with ASP9801 (monotherapy) ASP9801 + Pembrolizumab (combination therapy) will be assessed. The study will consist of the following periods: screening, initial treatment period (two 28 day cycles), optional extended treatment period (continued 28 day cycles) and a follow up period (safety and survival follow up).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation - cutaneous or subcutaneous lesions | Experimental | Biological: ASP9801Participants will receive ASP9801 (1x10^7 pfu/mL) on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Escalation - visceral lesions | Experimental | Biological: ASP9801Participants will receive ASP9801 (1x10^8 pfu/mL) on days 1 and 15 of 28 day cycles to determine the recommended phase 2 dose. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Monotherapy) - cutaneous or subcutaneous lesions | Experimental | Biological: ASP9801Participants will receive ASP9801 (1x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Monotherapy) - visceral lesions | Experimental | Biological: ASP9801Participants will receive ASP9801 (5x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Monotherapy Induction) - cutaneous or subcutaneous lesions | Experimental | Biological: ASP9801Participants will receive ASP9801 (5x10^8 pfu/mL) on days 1, 8, 15 and 22 of the first 28 day cycle. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Combination Therapy) - cutaneous or subcutaneous lesions | Experimental | Combination Product: PembrolizumabParticipants will receive ASP9801 (1x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Combination Induction Therapy) - cutaneous or subcutaneous lesions | Experimental | Combination Product: PembrolizumabParticipants will receive ASP9801 (5x10^8 pfu/mL) on days 1, 8, 15 and 22 of first 28 day cycle at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. Participants will receive ASP9801 on days 1 and 15 on the second 28 day cycle at the dose recommended by the dose escalation phase. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
| Dose Expansion (Combination Therapy) - visceral lesions | Experimental | Combination Product: PembrolizumabParticipants will receive ASP9801 (5x10^8 pfu/mL) on days 1 and 15 of 28 day cycles at the dose recommended by the dose escalation phase. Participants will also receive pembrolizumab starting on day 1 and once every 6 weeks. After cycle 2, participants who have not met any discontinuation criteria and receiving clinical benefit may be treated on continuous cycles until treatment discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject must have histologically- or cytologically-confirmed diagnosis of advanced or metastatic solid tumor(s).
- Subject has measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
- Subject has had disease progression after, been intolerant to, or has refused all available therapies that are known to confer clinical benefit. Note: There is no limit to the number of prior treatment regimens.
- Subject has a predicted life expectancy ≥ 12 weeks.
- Subject has at least 2 sites of disease suitable for biopsy and is willing and able to undergo required tumor biopsies according to the treating institution's guidelines at screening and during study treatment.
Key exclusion criteria (39 listed)
- Subject has ongoing toxicity ≥ National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant.
- Subject who has had major surgery ≤ 4 weeks of screening. Subjects must have recovered from prior procedures and/or any complications from surgery prior to starting study treatment.
- Subject is concurrently participating in another interventional study or has received an investigational product ≤ 30 days or 5 half-lives whichever is shorter, prior to first IP administration.
- Subject with symptomatic or untreated central nervous system (CNS) metastases or leptomeningeal disease. Subjects with treated symptomatic brain metastases should be neurologically stable (without evidence of progression by imaging for at least 4 weeks prior to screening and any neurologic symptoms have returned to baseline) and off steroids for at least 2 weeks prior to first IP administration. Subjects with carcinomatous meningitis are excluded regardless of clinical stability.
- Subject with active or prior autoimmune or inflammatory disorders requiring systemic therapy within past 2 years (including inflammatory skin conditions or severe eczema, inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
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 |
|---|---|---|
| ASP9801Administered by intratumoral injection | Biological | Dose Escalation - cutaneous or subcutaneous lesions, Dose Escalation - visceral lesions, Dose Expansion (Monotherapy Induction) - cutaneous or subcutaneous lesions, Dose Expansion (Monotherapy) - cutaneous or subcutaneous lesions, Dose Expansion (Monotherapy) - visceral lesions |
| PembrolizumabAlso: KEYTRUDA®Administered by Intravenous Infusion | Combination product | Dose Expansion (Combination Induction Therapy) - cutaneous or subcutaneous lesions, Dose Expansion (Combination Therapy) - cutaneous or subcutaneous lesions, Dose Expansion (Combination Therapy) - visceral lesions |
Primary outcome
Dose Limiting Toxicities (DLT) - dose escalation part
Time frame: Up to 28 days
Incidence of dose limiting toxicities
Safety and tolerability assessed by Adverse Events (AEs)
Time frame: Up to 12 months
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.
Number of participants with laboratory value abnormalities and/or adverse events
Time frame: Up to 12 months
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and /or adverse events
Time frame: Up to 12 months
Number of participants with potentially clinically significant vital sign values.
Safety assessed by 12- lead electrocardiograms (ECGs) adverse events
Time frame: Up to 12 months
12-lead ECGs will be read and assessed locally. Any clinically significant adverse changes on the ECG will be reported as Adverse Events.
8 secondary outcomes
Percent change from baseline in antitumor activity of ASP9801
Time frame: Up to 12 months
Objective Response Rate per imRECIST
Time frame: Up to 12 months
ASP9801 viral DNA in blood
Time frame: Up to 12 months
Viral shedding of ASP9801 in saliva
Time frame: Up to 12 months
Viral shedding of ASP9801 in urine
Time frame: Up to 12 months
Viral shedding of ASP9801 in skin (cutaneous/subcutaneous only)
Time frame: Up to 12 months
Objective Response Rate per Response Evaluation Criteria in Solid Tumors version (RECIST) 1.1
Time frame: Up to 12 months
Change in Programmed Cell Death Ligand 1 (PD-L1) Expression in Tumor
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- 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: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. 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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP9801 and Pembrolizumab in people with Metastatic Cancer and Solid Tumors, run by Astellas Pharma Global Development, Inc. at 17 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 17 inclusion and 39 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: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose Limiting Toxicities (DLT) - dose escalation part (time frame: Up to 28 days). The study lists 5 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 22 Apr 2025.