A Study of DS5361b in Participants With Advanced Solid Tumors
NCT ID: NCT07182591
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
192 participants
INTERVENTIONAL
2025-10-02
2030-12-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Monotherapy (Dose Escalation)
Participants will receive DS5361b at escalating doses.
DS5361b
Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE.
Dose Expansion Part: DS5361b will be administered at RDE.
Part 2: Combination Therapy (Dose Escalation)
Participants will receive DS5361b at escalating doses in combination with Pembrolizumab.
DS5361b
Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE.
Dose Expansion Part: DS5361b will be administered at RDE.
Pembrolizumab
Dose Escalation Part: Pembrolizumab will be administered at a standard dose.
Dose Expansion Part: Pembrolizumab will be administered at a standard dose.
Part 3: Combination Therapy (Dose Expansion)
Participants will receive DS5361b in combination with Pembrolizumab at the recommended dose for expansion (RDE).
DS5361b
Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE.
Dose Expansion Part: DS5361b will be administered at RDE.
Pembrolizumab
Dose Escalation Part: Pembrolizumab will be administered at a standard dose.
Dose Expansion Part: Pembrolizumab will be administered at a standard dose.
Interventions
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DS5361b
Dose Escalation Part: DS5361b will be administered at escalating doses to determine the RDE.
Dose Expansion Part: DS5361b will be administered at RDE.
Pembrolizumab
Dose Escalation Part: Pembrolizumab will be administered at a standard dose.
Dose Expansion Part: Pembrolizumab will be administered at a standard dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has histologically- or cytologically documented recurrent, metastatic, or unresectable solid tumors that are refractory to or intolerable with standard treatment or for which no standard treatment is available (For Part 1 and Part 2 only).
3. Participants need to have documented TMB or MSI status using a validated or approved genomic test as per applicable regulations prior to Cycle 1 Day 1. In Part 1 and Part 2, participants need to have documented TMB-H and/or MSI-H status. In Part 3, participants need to have documented TMB-H status.
4. Has measurable disease based on local CT/MRI imaging as assessment by the investigator using RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
6. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention.
7. For HNSCC participants only: have documented results from local testing of HPV for oropharyngeal cancer. If HPV status has previously been tested using this procedure, no retesting is required.
Dose Expansion (Part 3) Only:
8. Has histologically or cytologically confirmed, Stage IV NSCLC without actionable gene alteration.
* No prior systemic therapy.
* Participants with PD-L1 TPS ≥1%.
9. Has histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies.
* No prior systemic therapy administered in the recurrent or metastatic setting.
* Participants with PD-L1 CPS ≥1.
Exclusion Criteria
2. Has a history of leptomeningeal carcinomatosis.
3. Uncontrolled or significant cardiovascular disease.
4. Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
5. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out.
6. Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen).
7. Has any evidence of severe or uncontrolled systemic diseases.
8. Has active or uncontrolled HBV infection. Hepatitis B SCR testing is required.
9. Has active or uncontrolled HCV infection. Hepatitis C SCR testing is required.
10. For the dose escalation phase (Part 1 and Part 2), has HIV infection. For the dose expansion part (Part 3), has active or uncontrolled HIV infection.
11. Prior organ transplantation, including allogeneic stem cell transplantation.
12. Has an active, known, or suspected autoimmune disease.
13. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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Research Site
Irving, Texas, United States
Research Site
San Antonio, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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DS5361-061
Identifier Type: -
Identifier Source: org_study_id