A Study of DS-3939a in Participants With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DS-3939a, Pembrolizumab, Carboplatin, Pemetrexed.
- Who it may be relevant to
- Registry conditions: Solid Tumor, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1b/2, Multicenter, 2-part, Open-label Trial to Evaluate DS-3939a in Participants With Solid Tumors
Overview
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.
Detailed description
The study includes 2 independent substudies, which have been defined by treatment combination and participant population as follows:
1. Substudy 1 will evaluate the safety and efficacy of DS-3939a in combination with immunotherapy with or without chemotherapy (carboplatin or pemetrexed) in participants with locally advanced unresectable or metastatic non-squamous (NSQ) NSCLC in the first-line setting. 2. Substudy 2 will evaluate the safety and efficacy of DS-3939a in combination with DS-1103a or as a monotherapy in participants with locally advanced unresectable or metastatic NSQ NSCLC who are pretreated.
Each sub study will be conducted in 2 parts: Dose escalation (Part 1) and Dose expansion (Part 2). The allocation of participants in Part 1 will be non-randomized, and in Part 2, it will be randomized for both substudies.
Interventions
- Drug DS-3939a
DS-3939a will be administered as an IV infusion. - Drug Pembrolizumab
Pembrolizumab will be administered as an IV infusion. - Drug Carboplatin
Carboplatin will be administered as an IV infusion. - Drug Pemetrexed
Pemetrexed will be administered as an IV infusion. - Drug DS-1103a
DS-1103a will be administered as an IV infusion.
Primary outcome measures
- Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) [Time frame: During first cycle (Cycle length=21 days)]
- Part 1: Number of Participants With TEAEs [Time frame: Up to approximately 4 years]
- Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator [Time frame: Up to approximately 4 years]
Secondary outcome measures (12)
- Part 1: OR Per RECIST v1.1 as Assessed by Investigator [Time frame: Up to approximately 5 years]
- Part 2: Number of Participants With TEAEs [Time frame: Up to approximately 5 years]
- Parts 1 and 2: Duration of Response (DoR) [Time frame: Up to approximately 5 years]
- Parts 1 and 2: Disease Control Rate (DCR) [Time frame: Up to approximately 5 years]
- Parts 1 and 2: Time To Response (TTR) [Time frame: Up to approximately 5 years]
- Parts 1 and 2: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors [Time frame: Up to approximately 5 years]
- Parts 1 and 2: Progression-Free Survival (PFS) Per RECIST v1.1 as Assessed by Investigator [Time frame: Up to approximately 5 years]
- Parts 1 and 2: Overall Survival (OS) [Time frame: Up to approximately 5 years]
- Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Anti-TA-MUC1-ac-DXd, Total Anti-TA-MUC1 Antibody and MAAA-1181a [Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)]
- 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 [Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)]
- 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 [Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)]
- 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 [Time frame: Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 5 years (Cycle length=21 days)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07739966 · DS3939-156 · 2026-525218-75-00