NeoplasmsPhase 1/2NCT03416335
A Study of DSP-0509 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile
A Phase 1/2 study testing DSP-0509 and DSP-0509, Pembrolizumab in people with Neoplasms, run by Sumitomo Pharma America, Inc. at 5 sites in United States.
Trial summary
This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors. The study consists of 2 treatment arms - a monotherapy arm and a combination arm. The monotherapy arm has 1 part: Dose Escalation (Part A). The combination arm has Dose Escalation (Part B) only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- DSP-0509 and DSP-0509, Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2018to 20 Dec 2022
- 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
- Patients must fulfill each of the following requirements:
- 1. Must have a histologically or cytologically confirmed advanced solid tumor that meets the following additional specifications
- Monotherapy Part A (Dose Escalation) advanced solid tumor that is metastatic or unresectable and recurrent and /or refractory to available therapy.
- Combination Part B (Dose Escalation)- advanced solid tumors that are (a) metastatic or unresectable and recurrent and/or refractory to available therapy; (b) a condition for which pembrolizumab is an approved treatment: and (c) in patients who either have shown primary or acquired resistance to immune checkpoint inhibitors (ICIs)
- Combination Arm C (Dose Expansion), Phase 2 - Advanced HNSCC tumors of the oropharynx, oral cavity, hypopharynx, larynx, lip, or sinus that are (a) metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in monotherapy, and (c) who have subsequently shown primary or acquired resistance to ICIs.
- For enrollment in both arms:
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- 2. Must be ≥ 18 years of age
- 3. Should have all side effects of any prior therapy or procedures for any medical condition recovered to CTCAE ≤ Grade 1 (except alopecia).
- 4. Must have at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1.
- 5. Must have a life expectancy ≥ 3 to 6 months.
- 6. Female patients of childbearing age and women < 12 months since the onset of menopause, except those who have been surgically sterilized (tubal ligation) or whose sexual partner(s) is surgically sterilized (vasectomy), must agree to use acceptable contraceptive methods for the duration of the study and for 9 months after the date of their last DSP-0509 infusion. If employing contraception, 2 of the following precautions must be used: birth control pill, vaginal diaphragm, intrauterine system or device, condom or vaginal spermicide. Female patients who are postmenopausal are defined as those with an absence of menses for ≥ 12 consecutive months. Male patients must be surgically sterilized (vasectomy) or their female sexual partner(s) must be surgically sterilized (tubal ligation) to avoid using contraception. If they do not meet this criterion, then male patients or must agree to use a condom as well as one of the acceptable contraceptive methods listed above with their female partner(s) who meets the criteria of either being of childbearing age or is < 12 months since the onset of menopause. Male patients and their female partner(s) must agree to use acceptable contraception methods for the duration of time the male patient is on the study and for 9 months after the date of his last DSP 0509 infusion.
- 7. Females of childbearing potential must have a negative serum pregnancy test.
- 8. Must have an Eastern Cooperative Oncology Group performance status of 0 to 1.
- 9. Must have adequate coagulation function at Screening as determined by:
- Prothrombin international normalized ratio < 1.5. b. Partial thromboplastin time < 1.5 times the upper limit of normal (ULN).
- 10. Must have adequate hematologic function at Screening as determined by:
- White blood cell (WBC) count ≥ 3,000/microliter. b. Absolute neutrophil count (ANC) ≥ 1,500/microliter (patient may not use granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor to achieve these WBC and ANC levels).
- Platelet count ≥ 100 × 103/microliter. d. Hemoglobin (Hgb) ≥ 9.0 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level).
- 11. Must have adequate renal and hepatic function at Screening as determined by:
- Serum creatinine < 2.0 mg/dL or < 1.5 times the ULN, whichever is lower.
- Total bilirubin ≤ 1.5 mg/dL or < 1.5 times the ULN, whichever is lower (or ≤ 2.0 mg/dL for patients with known Gilbert syndrome).
- Aspartate aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases).
- Alanine aminotransferase ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver metastases).
- 12. Must be able to attend study visits as required by the protocol.
- 13. Prior to the first DSP-0509 infusion, the patient must be able to provide tumor tissue for baseline studies either as (a) a block of archival tissue sufficient to provide the required number of slides (b) a sufficient number of fixed, unstained slides of archival tissue or (c) consent to undergo tumor biopsy to acquire sufficient tumor tissue. (Sites need to refer to the current version of the "Sample Collection \& Shipment Instructions Manual" to determine how many slides are required for each patient as these numbers vary based on (a) the study Arm/Part in which the patient is enrolled and (b) whether the patient consented to optional future testing).
- In addition to the above criteria, patients must meet the following criteria to be eligible to enroll in Combination Arm C:
- 14. Have at least one accessible tumor for biopsy. This accessible lesion must be considered as non-measurable per RECIST criteria, v1.1.
- 15. Be platinum refractory, PD-1 or PD-L1 exposed, and have no more than 3 lines of prior therapy for advanced/metastatic disease
- 16. Have a known status of PD-L1 combined positive score (CPS)
- 17. Have a known HPV status
Who cannot join
- Patients with any of the following will be excluded from the study:
- For enrollment in both arms:
- Has received prior therapy with a TLR agonist, excluding a topical TLR agonist.
- Has received anticancer chemotherapy (including molecular-targeted drugs), radiotherapy, immunotherapy (eg, vaccines or cytokines), or investigational agents within the 3 weeks before the first dose of DSP-0509. Local palliative radiotherapy is permitted3. Receives concurrent systemic (oral or IV) steroid therapy > 10 mg prednisone daily or its equivalent for an underlying condition.
- 4. Not fully recovered from major surgery before the first dose of DSP-0509.
- 5. Has central nervous system (CNS) metastases (including leptomeningeal metastases, spinal metastases) or CNS primary tumors, eg, glioblastoma.
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- 6. Has a history of seizures other than isolated febrile seizure in childhood; has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago.
- 7. Has effusions (pleural, pericardial, or ascites) requiring drainage.
- 8. Has a neurodegenerative disease, eg, motor neuron disease, Parkinson disease, Alzheimer disease, Huntington disease.
- 9. Has retinal detachment, ulcerative keratitis, uveitis, Vogt-Koyanagi-Harada syndrome, choroidal neovascularization, retinopathy/retinitis, thyroid-associated orbitopathy, idiopathic orbital inflammation, diabetic retinopathy, ischemic retinopathy including glaucoma-associated retinopathy, retinal vein thrombosis, or a non-healing ocular or ophthalmic disease.
- 10. Has a fever ≥ 38°C within 3 days before the first dose of study treatment.
- 11. Has interstitial lung disease or active noninfectious pneumonitis.
- 12. Has a history of active autoimmune or immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents (eg, azathioprine, cyclosporine A) except for patients with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and euthyroid patients with a history of Grave disease. Patients with controlled hyperthyroidism must be negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid-stimulating immunoglobulin before study drug administration.
- 13. Has a known hypersensitivity to a component of the protocol therapy, DSP-0509, or another pyrimidine.
- 14. Has a history of another primary cancer within the 5 years before enrollment except for the following: non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, or other nonmetastatic carcinoma that has been in complete remission without treatment for more than 5 years.
- 15. Has abnormal ECGs that are clinically significant, such as QT prolongation (QTc > 480 msec).
- 16. In the opinion of the treating Investigator, has any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the study results; these conditions include, but are not limited to ongoing or active infection, clinically significant non-healing or healing wounds, concurrent congestive heart failure (New York Heart Association Functional Classification Class II, III or IV), concurrent unstable angina, concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation), recent (within the prior 12 months) myocardial infarction, acute coronary syndrome within the previous 12 months, significant pulmonary disease (shortness of breath at rest or on mild exertion) for example due concurrent severe obstructive pulmonary disease, concurrent hypertension requiring more than 2 medications for adequate control, or diabetes mellitus with more than 2 episodes of ketoacidosis in the prior 12 months.
- 17. Has an ejection fraction of 50% or less based on a MUGA scan or ECHO.
- 18. Has the presence of a known active acute or chronic infection including human immunodeficiency virus as determined by enzyme-linked immunosorbent assay and confirmed by Western blot; and hepatitis B virus and hepatitis C virus as determined by hepatitis B surface antigen and hepatitis C serology.
- 19. Has a cognitive, psychological, or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocol or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures.
- 20. Receives concurrent strong inhibitors of cytochrome P450 2C8.
- 21. Receives concurrent inhibitors of organic anion transporting peptide (OATP)1B1 and OATP1B3.
- 22. Is pregnant or breastfeeding.
- 23. Has active neurological or inflammatory or auto immune disorders (e.g. Guillain-Barre Syndrome, Amyotrophic Lateral Sclerosis)
- The following exclusion applies only to enrollment in Combination arms Part B \& C:
- 24. Has a history of immune-related adverse events (irAEs) resulting in permanent discontinuation of ICI treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 25799
M.D. Anderson Cancer Center, The University of Texas
Houston, Texas, 77030
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Henry-Joyce Cancer Center, Vanderbilt University
Nashville, Tennessee, 37232
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A First-in-Human Phase 1/2 Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0509, a Synthetic Toll-Like Receptor 7 (TLR-7) Agonist, Administered as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors. The study consists of 2 treatment arms - a monotherapy arm and a combination arm. The monotherapy arm has 1 part: Dose Escalation (Part A). The combination arm has Dose Escalation (Part B) only.
Read the detailed description
The primary objective of Monotherapy Arm A is to determine the MTD or RP2D of DSP-0509 when administered as a single agent. Approximately 21 to 30 patients with advanced solid tumors will be enrolled. Several provisional dose levels of DSP-0509, with approximately 3 to 6 patients at each level may be tested in patients with advanced solid tumors. DSP-0509 will be administered as a single agent q2w beginning on Day 1.
The primary objective of Combination Therapy Arm B is to determine the RP2D of DSP-0509 when administered in combination with pembrolizumab, using a BLRM approach. The combination arm will enroll approximately 21 to 30 patients with advanced solid tumors that are (a) metastatic or unresectable and recurrent, and/or refractory to available therapy, (b) a condition for which pembrolizumab is an approved treatment, and (c) in patients who have shown either primary or acquired resistance to an ICI. DSP-0509 will be administered on Day 1 and then every 2 weeks thereafter. Pembrolizumab will be initiated on Day 1.
The primary objective of Combination Therapy Arm C is to determine preliminary efficacy in the form of the ORR of DSP-0509 when administered in combination with pembrolizumab to an expansion cohort of patients with HNSCC, using a Bayesian Adaptive design approach. Combination Arm C will enroll approximately 20 to 40 patients with HNSCC tumors that are (a) metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in monotherapy, and (c) who have subsequently shown either primary or acquired resistance to ICIs.
Dose escalation of DSP-0509 in combination with 400 mg pembrolizumab q6w will start at the same dose of DSP-0509 as the highest (not exceeding the MTD) level tested in the combination regimen with 200 mg pembrolizumab q3w. Upon completion of the DLT evaluation period for the first DSP-0509 dose level tested in combination with 400 mg pembrolizumab q6w in newly enrolled patients, if this dose level is found not to exceed the MTD, any ongoing patients receiving DSP-0509 in combination with pembrolizumab 200 mg q3w will be allowed, at the investigator's discretion, to transition to the 400 mg pembrolizumab q6w regimen, while maintaining the originally assigned DSP-0509 dose level.
- Conditions
- Neoplasms
- Being tested
- DSP-0509, DSP-0509, Pembrolizumab
- Keywords
- DSP-0509, Toll-Like Receptor 7 (TLR-7), BLRM (Bayesian Logistic Regression Model)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-0509Drug
Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump.
DSP-0509, PembrolizumabDrug
Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (200 mg IV q3w)
DSP-0509, PembrolizumabDrug
Each patient treated will receive DSP-0509 at the Recommended Phase II Dose (RP2D) level as determined in Part B. It is given as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (400 mg IV q6w)
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Arm - Part A | Experimental | Dose Escalation Drug DSP-0509 Receives: Drug: DSP-0509 |
| Combination arm - Part B | Experimental | Dose Escalation Drug DSP-0509, Pembrolizumab Receives: Drug: DSP-0509, Pembrolizumab |
| Combination arm - Part C | Experimental | Dose Expansion, Drug DSP-0509, Pembrolizumab Receives: Drug: DSP-0509, Pembrolizumab |
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) Within the First 6 Weeks of Dosing
Measured: From the time of first dose to 6 weeks after the first dose
Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs)
Measured: 28 days
Determination of the MTD of DSP-0509 When Given in Combination With Pembrolizumab by Assessing Dose-limiting Toxicities (DLTs).
MTD of DSP-0509 in patients enrolled into the Combination Arm during the dose escalation part of the study.
Measured: 28 days
Determination of RP2D of DSP-0509 When Given in Combination With Pembrolizumab by Assessing DLTs
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1).
Measured: 28 days
Preliminary Antitumor Activity of DSP-0509 in Combination With Pembrolizumab in Patients With Head & Neck Squamous Cell Carcinoma (HNSCC) Who Have Shown Primary or Acquired Resistance to Immune Checkpoint Inhibitors (ICIs)
Data to be derived from patients enrolled into the Combination Arm - Part C (Phase 2)
Measured: 4 weeks
Secondary outcomes (10)
Evaluate Pharmacokinetics (PK) for Single Agent DSP-0509 by Assessing Plasma Concentration.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Measured: 8 weeks
Objective Response Rate (ORR) by RECIST
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From date of first dose to 6 months post first dose
ORR by Immune RECIST (iRECIST)
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on iRECIST.
Measured: From date of first dose to 6 months post first dose
Duration of Response (DoR) by RECIST
Defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1.
Measured: 6 months
DoR by iRECIST
Defined as the time from first documentation of response until the time of first documentation of disease progression by iRECIST.
Measured: 6 months
Progression Free Survival (PFS) by RECIST
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by RECIST v1.1.
Measured: 12 months
PFS by iRECIST
Defined as the time from first dose to the earlier date of assessment of progression or death by any cause in the absence of progression by iRECIST.
Measured: 12 months
Evaluate Single Agent DSP-0509-induced Changes in Cytokine Levels.
Data to be derived from patients enrolled into the Monotherapy Arm - Part A (Phase 1)
Measured: 8 weeks
Evaluate Change in Cytokine Levels Induced by DSP-0509 in Combination With Pembrolizumab.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
Measured: 8 weeks
Evaluate Pharmacokinetics (PK) for Combo Agents DSP-0509 and Pembrolizumab by Assessing Plasma Concentration.
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start1 Jun 2018
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Why it stopped: Sponsor's decision to terminate the development of the program due to changing landscape.
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 NeoplasmsStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416335
- Sponsor's protocol ID
- BBI-DSP0509-101
- Status last verified
- May 2024
- First submitted
- 24 Jan 2018
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Phase 1/2 Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0509, a Synthetic Toll-Like Receptor 7 (TLR-7) Agonist, Administered as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03416335
- Acronym / sponsor ID
- BBI-DSP0509-101
- Conditions
- Neoplasms
- Keywords
- DSP-0509, Toll-Like Receptor 7 (TLR-7), BLRM (Bayesian Logistic Regression Model)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision to terminate the development of the program due to changing landscape.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, Phase 1 / 2 clinical study for patients with advanced solid tumors. The study consists of 2 treatment arms - a monotherapy arm and a combination arm. The monotherapy arm has 1 part: Dose Escalation (Part A). The combination arm has Dose Escalation (Part B) only.
Detailed description
The primary objective of Monotherapy Arm A is to determine the MTD or RP2D of DSP-0509 when administered as a single agent. Approximately 21 to 30 patients with advanced solid tumors will be enrolled. Several provisional dose levels of DSP-0509, with approximately 3 to 6 patients at each level may be tested in patients with advanced solid tumors. DSP-0509 will be administered as a single agent q2w beginning on Day 1.
The primary objective of Combination Therapy Arm B is to determine the RP2D of DSP-0509 when administered in combination with pembrolizumab, using a BLRM approach. The combination arm will enroll approximately 21 to 30 patients with advanced solid tumors that are (a) metastatic or unresectable and recurrent, and/or refractory to available therapy, (b) a condition for which pembrolizumab is an approved treatment, and (c) in patients who have shown either primary or acquired resistance to an ICI. DSP-0509 will be administered on Day 1 and then every 2 weeks thereafter. Pembrolizumab will be initiated on Day 1.
The primary objective of Combination Therapy Arm C is to determine preliminary efficacy in the form of the ORR of DSP-0509 when administered in combination with pembrolizumab to an expansion cohort of patients with HNSCC, using a Bayesian Adaptive design approach. Combination Arm C will enroll approximately 20 to 40 patients with HNSCC tumors that are (a) metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in monotherapy, and (c) who have subsequently shown either primary or acquired resistance to ICIs.
Dose escalation of DSP-0509 in combination with 400 mg pembrolizumab q6w will start at the same dose of DSP-0509 as the highest (not exceeding the MTD) level tested in the combination regimen with 200 mg pembrolizumab q3w. Upon completion of the DLT evaluation period for the first DSP-0509 dose level tested in combination with 400 mg pembrolizumab q6w in newly enrolled patients, if this dose level is found not to exceed the MTD, any ongoing patients receiving DSP-0509 in combination with pembrolizumab 200 mg q3w will be allowed, at the investigator's discretion, to transition to the 400 mg pembrolizumab q6w regimen, while maintaining the originally assigned DSP-0509 dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Arm - Part A | Experimental | Drug: DSP-0509Dose Escalation Drug DSP-0509 |
| Combination arm - Part B | Experimental | Drug: DSP-0509, PembrolizumabDose Escalation Drug DSP-0509, Pembrolizumab |
| Combination arm - Part C | Experimental | Drug: DSP-0509, PembrolizumabDose Expansion, Drug DSP-0509, Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 1. Must have a histologically or cytologically confirmed advanced solid tumor that meets the following additional specifications
- Monotherapy Part A (Dose Escalation) advanced solid tumor that is metastatic or unresectable and recurrent and /or refractory to available therapy.
- Combination Part B (Dose Escalation)- advanced solid tumors that are (a) metastatic or unresectable and recurrent and/or refractory to available therapy; (b) a condition for which pembrolizumab is an approved treatment: and (c) in patients who either have shown primary or acquired resistance to immune checkpoint inhibitors (ICIs)
- Combination Arm C (Dose Expansion), Phase 2 - Advanced HNSCC tumors of the oropharynx, oral cavity, hypopharynx, larynx, lip, or sinus that are (a) metastatic or unresectable, and recurrent and/or refractory to available therapy, (b) in patients who have been treated with pembrolizumab or other PD-1 or PD-L1 inhibitors in monotherapy, and (c) who have subsequently shown primary or acquired resistance to ICIs.
- 2. Must be ≥ 18 years of age
Key exclusion criteria (26 listed)
- 4. Not fully recovered from major surgery before the first dose of DSP-0509.
- 5. Has central nervous system (CNS) metastases (including leptomeningeal metastases, spinal metastases) or CNS primary tumors, eg, glioblastoma.
- 6. Has a history of seizures other than isolated febrile seizure in childhood; has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago.
- 7. Has effusions (pleural, pericardial, or ascites) requiring drainage.
- 8. Has a neurodegenerative disease, eg, motor neuron disease, Parkinson disease, Alzheimer disease, Huntington disease.
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 |
|---|---|---|
| DSP-0509Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump. | Drug | Monotherapy Arm - Part A |
| DSP-0509, PembrolizumabEach patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (200 mg IV q3w) | Drug | Combination arm - Part B |
| DSP-0509, PembrolizumabEach patient treated will receive DSP-0509 at the Recommended Phase II Dose (RP2D) level as determined in Part B. It is given as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (400 mg IV q6w) | Drug | Combination arm - Part C |
Primary outcome
Number of Participants With Dose-limiting Toxicities (DLTs) Within the First 6 Weeks of Dosing
Time frame: From the time of first dose to 6 weeks after the first dose
Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs)
Time frame: 28 days
Determination of the MTD of DSP-0509 When Given in Combination With Pembrolizumab by Assessing Dose-limiting Toxicities (DLTs).
Time frame: 28 days
MTD of DSP-0509 in patients enrolled into the Combination Arm during the dose escalation part of the study.
Determination of RP2D of DSP-0509 When Given in Combination With Pembrolizumab by Assessing DLTs
Time frame: 28 days
Data to be derived from patients enrolled into the Combination Arm - Part B (Phase 1).
Preliminary Antitumor Activity of DSP-0509 in Combination With Pembrolizumab in Patients With Head & Neck Squamous Cell Carcinoma (HNSCC) Who Have Shown Primary or Acquired Resistance to Immune Checkpoint Inhibitors (ICIs)
Time frame: 4 weeks
Data to be derived from patients enrolled into the Combination Arm - Part C (Phase 2)
10 secondary outcomes
Evaluate Pharmacokinetics (PK) for Single Agent DSP-0509 by Assessing Plasma Concentration.
Time frame: 8 weeks
Objective Response Rate (ORR) by RECIST
Time frame: From date of first dose to 6 months post first dose
ORR by Immune RECIST (iRECIST)
Time frame: From date of first dose to 6 months post first dose
Duration of Response (DoR) by RECIST
Time frame: 6 months
DoR by iRECIST
Time frame: 6 months
Progression Free Survival (PFS) by RECIST
Time frame: 12 months
PFS by iRECIST
Time frame: 12 months
Evaluate Single Agent DSP-0509-induced Changes in Cytokine Levels.
Time frame: 8 weeks
Evaluate Change in Cytokine Levels Induced by DSP-0509 in Combination With Pembrolizumab.
Time frame: 8 weeks
Evaluate Pharmacokinetics (PK) for Combo Agents DSP-0509 and Pembrolizumab by Assessing Plasma Concentration.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 DSP-0509 and DSP-0509, Pembrolizumab in people with Neoplasms, run by Sumitomo Pharma America, Inc. at 5 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 30 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 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 30 May 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) Within the First 6 Weeks of Dosing (time frame: From the time of first dose to 6 weeks after the first dose). 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 30 May 2024.