A Study of DS-3939a in Participants With Solid Tumors

Sponsor
Daiichi Sankyo
Study ID
NCT07739966
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Non-Small Cell Lung Cancer
  • Metastatic Non-Small Cell Lung Cancer
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DS-3939a — DRUG
    DS-3939a will be administered as an IV infusion.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered as an IV infusion.
  • Carboplatin — DRUG
    Carboplatin will be administered as an IV infusion.
  • Pemetrexed — DRUG
    Pemetrexed will be administered as an IV infusion.
  • DS-1103a — DRUG
    DS-1103a will be administered as an IV infusion.

Study Details

The primary purpose of the study is to evaluate the safety, tolerability, and efficacy of DS-3939a in combination with other anticancer agents or as a monotherapy in participants with solid tumors.

Key Dates

First listed
Jul 31, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2030
Completion
Jan 29, 2032

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1: Part 1: Cohort A: DS-3939a + Pembrolizumab
    Participants will receive intravenous (IV) infusion of DS-3939a, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 milligrams (mg), Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles or until treatment discontinuation criteria are me.
  • Experimental: Substudy 1: Part 1: Cohort B: DS-3939a + Pembrolizumab + Carboplatin
    Participants will receive IV infusion of DS-3939a, Q3W on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per RECIST v1.1 by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and carboplatin at area under the curve (AUC) 5, Q3W on Day 1 of each 21-day cycle up to maximum of 4 cycles or until the discontinuation criteria are met.
  • Experimental: Substudy 1: Part 1: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed
    Participants will receive IV infusion of DS-3939a, Q3W on Day 1 of each 21-day cycle until the time radiographic disease progression has been documented as assessed per RECIST v1.1 by investigator or other reason for treatment discontinuation has been met along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and pemetrexed 500 milligrams per meter square (mg/m\^2), Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met.
  • Experimental: Substudy 1: Part 2: Cohort A: DS-3939a + Pembrolizumab
    Participants will receive IV infusion of DS-3939a at the recommended dose for expansion (RDE) based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles or until the discontinuation criteria are met.
  • Experimental: Substudy 1: Part 2: Cohort B: DS-3939a + Pembrolizumab + Carboplatin
    Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and carboplatin at AUC 5, Q3W on Day 1 of each 21-day cycle up to a maximum of 4 cycles or until the discontinuation criteria are met.
  • Experimental: Substudy 1: Part 2: Cohort C: DS-3939a + Pembrolizumab + Pemetrexed
    Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles and pemetrexed 500 mg/m\^2, Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met.
  • Active Comparator: Substudy 1: Part 2: Cohort D: Pembrolizumab + Carboplatin + Pemetrexed
    Participants will receive IV infusions of pembrolizumab, 200 mg, Q3W on Day 1 of each 21-day cycle up to a maximum of 35 cycles, along with carboplatin at AUC 5, Q3W on Day 1 of each 21-day cycle up to maximum of 4 cycles and pemetrexed 500 mg/m\^2, Q3W on Day 1 of each 21-day cycle until the discontinuation criteria are met.
  • Experimental: Substudy 2: Part 1: DS-3939a + DS-1103a
    Participants will receive IV infusion of DS-3939a, along with DS-1103a, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met.
  • Experimental: Substudy 2: Part 2: DS-3939a + DS-1103a
    Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, along with DS-1103a, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met.
  • Active Comparator: Substudy 2: Part 2: DS-3939a
    Participants will receive IV infusion of DS-3939a at the RDE based on Part 1 data, Q3W on Day 1 of each 21-day cycle until radiographic disease progression as assessed by investigator, or other reason for treatment discontinuation criteria are met.

Primary Outcome Measure

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: During first cycle (Cycle length=21 days) ]

Central Contacts

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