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.
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.
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.
Parallel
DS-3939a
DrugDS-3939a will be administered as an IV infusion.
Pembrolizumab
DrugPembrolizumab will be administered as an IV infusion.
Carboplatin
DrugCarboplatin will be administered as an IV infusion.
Pemetrexed
DrugPemetrexed will be administered as an IV infusion.
DS-1103a
DrugDS-1103a will be administered as an IV infusion.
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Treatment groupsSee each treatment group below.
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
DLT is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc., that occurs during the DLT-evaluation Period (Day 1 to the end of Cycle 1) and is Grade ≥3. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0.
Part 1: Number of Participants With TEAEs
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 50 days after the last dose date of trial intervention, unless otherwise specified in the applicable sub-study protocol).
Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator
OR is defined as participants with a best overall response (BOR) of confirmed response (CR) or confirmed partial response (PR) as assessed by investigator per RECIST v1.1.
Part 1: OR Per RECIST v1.1 as Assessed by Investigator
OR is defined as participants with a BOR of confirmed CR or confirmed PR as assessed by investigator per RECIST v1.1.
Part 2: Number of Participants With TEAEs
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 50 days after the last dose date of trial intervention, unless otherwise specified in the applicable sub-study protocol).
Parts 1 and 2: Duration of Response (DoR)
DoR is defined as the time (month) from date of initial response (CR or PR) to the earlier date of the first objective documentation of radiographic disease progression or death due to any cause.
Parts 1 and 2: Disease Control Rate (DCR)
Disease control is defined as participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) per RECIST v1.1. DCR is defined as the percentage of participants with disease control.
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