A Study of DS-3939a in Participants With Solid Tumors | NCT07739966

NCT07739966

Overview

NCT ID: NCT07739966
Lead Sponsor: Daiichi SankyoINDUSTRY
Official Title: A Phase 1b/2, Multicenter, 2-part, Open-label Trial to Evaluate DS-3939a in Participants With Solid Tumors
Brief Summary: 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.
Conditions: Solid Tumor
Locally Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
Interventions: DS-3939a

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Jul 31, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.

Adults greater than or equal to (≥)18 years of age at the time the Main Trial ICF is signed (follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).

Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC.

Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days of the first trial intervention.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions.

Has adequate organ function.

Participants must have measurable disease by investigator assessment according to RECIST v1.1.

Additional Inclusion Criteria for Substudy 1:

1. Participants must not have received prior systemic therapy for locally advanced unresectable or metastatic NSCLC.

Additional Inclusion Criteria for Substudy 2:

Participants with AGA (excluding EGFR mutation): Participants have been previously treated with targeted therapy for the AGA and platinum-based chemotherapy for the advanced disease setting.

Participants without AGA: Participants have been previously treated with platinum-based chemotherapy and anti-programmed death-1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) antibody

Part 2 only: Participants must have received only 1 or 2 prior lines of anticancer therapy for the advanced disease setting.

Exclusion Criteria:

Prior systemic anticancer therapy targeting MUC1 or TA-MUC1.

Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan).

Has spinal cord compression or clinically active central nervous system (CNS) metastases.

Has multiple primary malignancies.

Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening

Has active or uncontrolled human immunodeficiency virus (HIV) infection.

Has active or uncontrolled hepatitis B virus (HBV)/hepatitis C virus (HCV) infection.

Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.

Current participation in other therapeutic investigational procedures, except for participation in long term survival follow-up (LTSFU) without any investigational treatment.

Study Plan

Study Type: Interventional
Phase: Phase 1Phase 2
Enrollment: 400Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Daiichi Sankyo Contact for Clinical Trial InformationContact
CTRinfo_us@daiichisankyo.com

Similar Studies

Participant Group/Arms

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.

Drug: DS-3939a

Drug: Pembrolizumab

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.

Drug: DS-3939a

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.

Drug: DS-3939a

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.

Drug: DS-3939a

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.

Drug: DS-3939a

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.

Drug: DS-3939a

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.

Drug: Pembrolizumab

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.

Drug: DS-3939a

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.

Drug: DS-3939a

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.

Drug: DS-3939a