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NCT07739966

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

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 2 of 76 sites
  2. Notable Recruitment opened Show 5 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Trial sites expanded: 0 → 76 locations
    • Start date changed from estimate of Oct 1, 2026 to Oct 13, 2026
    • Secondary endpoints: details revised at 3 of 20 entries
    • Study description expanded, about 2 words
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: During first cycle (Cycle length=21 days)
Part 1: Number of Participants With TEAEs
Timeframe: Up to approximately 4 years
Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator
Timeframe: Up to approximately 4 years

Secondary (20)

Part 1: OR Per RECIST v1.1 as Assessed by Investigator
Part 2: Number of Participants With TEAEs
Parts 1 and 2: Duration of Response (DoR)
Parts 1 and 2: Disease Control Rate (DCR)
Parts 1 and 2: Time To Response (TTR)
Show 15 moreShow less
Parts 1 and 2: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors
Parts 1 and 2: Progression-Free Survival (PFS) Per RECIST v1.1 as Assessed by Investigator
Parts 1 and 2: Overall Survival (OS)
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Parts 1 and 2: Time to Reach Maximum Plasma Concentration (Tmax) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Parts 1 and 2: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Parts 1 and 2: Area Under the Concentration-time Curve up to Time Tau (AUCtau) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Parts 1 and 2: Trough Concentration (Ctrough) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a
Parts 1 and 2: Percentage of Participants With Positive Anti-Drug Antibody (ADA) Against DS-3939a
Substudy 2: AUClast of DS-1103a Dosed in Combination With DS-3939a
Substudy 2: AUCtau of DS-1103a Dosed in Combination With DS-3939a
Substudy 2: Cmax of DS-1103a Dosed in Combination With DS-3939a
Substudy 2: Tmax of DS-1103a Dosed in Combination With DS-3939a
Substudy 2: Ctrough of DS-1103a Dosed in Combination With DS-3939a
Substudy 2: Percentage of Participants With Positive ADA for DS-1103a Dosed in Combination With DS-3939a

Arms and interventions

Substudy 1: Part 1: Cohort A: DS-3939a + PembrolizumabExperimental

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.

Substudy 1: Part 1: Cohort B: DS-3939a + Pembrolizumab + CarboplatinExperimental

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.

Substudy 1: Part 1: Cohort C: DS-3939a + Pembrolizumab + PemetrexedExperimental

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.

Substudy 1: Part 2: Cohort A: DS-3939a + PembrolizumabExperimental

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.

Substudy 1: Part 2: Cohort B: DS-3939a + Pembrolizumab + CarboplatinExperimental

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.

Substudy 1: Part 2: Cohort C: DS-3939a + Pembrolizumab + PemetrexedExperimental

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.

Substudy 1: Part 2: Cohort D: Pembrolizumab + Carboplatin + PemetrexedActive comparator

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.

Substudy 2: Part 1: DS-3939a + DS-1103aExperimental

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.

Substudy 2: Part 2: DS-3939a + DS-1103aExperimental

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.

Substudy 2: Part 2: DS-3939aActive comparator

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.

Drugs: DS-3939a, Pembrolizumab, Carboplatin, Pemetrexed, DS-1103a

Sites

76 sites in 13 countries

China 15, France 8, Spain 8, Italy 7, United States 7, Brazil 6, Turkey (Türkiye) 6, Argentina 5, Japan 5, Taiwan 4, Austria 2, Belgium 2, Tunisia 1