Ireland
--:--IST
Recruiting Phase 1/2

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

NCT07739966 · tracked via the Priya Life Science France tracker
Phase
Phase 1/2
Started
2026-10-13
Last updated
2026-10-28

Condition(s) studied

Solid TumorLocally Advanced Non-Small Cell Lung CancerMetastatic Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

DS-3939a →Pembrolizumab →Carboplatin →Pemetrexed →DS-1103a →

DS-3939a: DS-3939a will be administered as an IV infusion.

Pembrolizumab: Pembrolizumab will be administered as an IV infusion.

Carboplatin: Carboplatin will be administered as an IV infusion.

Pemetrexed: Pemetrexed will be administered as an IV infusion.

DS-1103a: DS-1103a will be administered as an IV infusion.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures. 2. 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). 3. Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions. 6. Has adequate organ function. 7. 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: 1. 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. 2. 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 3. Part 2 only: Participants must have received only 1 or 2 prior lines of anticancer therapy for the advanced disease setting. Exclusion Criteria: 1. Prior systemic anticancer therapy targeting MUC1 or TA-MUC1. 2. Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan). 3. Has spinal cord compression or clinically active central nervous system (CNS) metastases. 4. Has multiple primary malignancies. 5. 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 6. Has active or uncontrolled human immunodeficiency virus (HIV) infection. 7. Has active or uncontrolled hepatitis B virus (HBV)/hepatitis C virus (HCV) infection. 8. Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. 9. Current participation in other therapeutic investigational procedures, except for participation in long term survival follow-up (LTSFU) without any investigational treatment.

Primary outcome measure(s)

  • Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) — During first cycle (Cycle length=21 days)
    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 — Up to approximately 4 years
    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 — Up to approximately 4 years
    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.

Trial sites (76)

FacilityCityRegionStatus
Highlands Oncology Group (Hog) - Fayetteville Fayetteville Arkansas Recruiting
UCLA Health Los Angeles California Not Yet Recruiting
Moffitt Cancer Center - Magnolia Campus Tampa Florida Not Yet Recruiting
Oregon Health & Science University Portland Oregon Not Yet Recruiting
Lifespan Cancer Institute - Rhode Island Hospital Providence Rhode Island Not Yet Recruiting
The University of Texas Md Anderson Cancer Center Houston Texas Not Yet Recruiting
Inova Schar Cancer Institute Fairfax Virginia Not Yet Recruiting
Instituto Alexander Fleming Buenos Aires Argentina Not Yet Recruiting
Instituto Oncologico de Cordoba (Ionc) - Fundacion Richardet Longo Córdoba Argentina Not Yet Recruiting
Sanatorio Parque Rosario Argentina Not Yet Recruiting
Cer San Juan - Centro Polivalente de Asistencia E Investigacion Clinica San Juan Argentina Not Yet Recruiting
Clinica Viedma S.A. Viedma Argentina Not Yet Recruiting
Medizinische Universitat Innsbruck Innsbruck Austria Not Yet Recruiting
Karl Landsteiner Institut Fur Lungenforschung Und Pneumologische Onkologie Vienna Austria Not Yet Recruiting
Universite Libre de Bruxelles (Ulb) - Institut Jules Brussels Belgium Not Yet Recruiting
Jessa Ziekenhuis - Hartcentrum Hasselt Sint-Truiden Belgium Not Yet Recruiting
Fundacao Pio Xii-Hospital de Cancer de Barretos Barretos Brazil Not Yet Recruiting
Liga Norte Riograndense Contra O Cancer - Pesquisa Clinica Natal Brazil Not Yet Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil Not Yet Recruiting
Hospital Sao Lucas Da Pucrs Porto Alegre Brazil Not Yet Recruiting
Obras Sociais Irma Dulce - Centro de Pesquisa Oncologica E Clinica (Cpoc) Salvador Brazil Not Yet Recruiting
Hospital Israelita Albert Einstein São Paulo Brazil Not Yet Recruiting
Beijing Chest Hospital, Capital Medical University Beijing China Not Yet Recruiting
Jilin Cancer Hospital Changchun China Not Yet Recruiting
Hunan Cancer Hospital Changsha China Not Yet Recruiting
The First Affiliated Hospital, Sun Yat-Sen University Guangzhou China Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine (Zhejiang Provincial First Hos Hangzhou China Not Yet Recruiting
Zhejiang Cancer Hospital Hangzhou China Not Yet Recruiting
Harbin Medical University Cancer Hospital Harbin China Not Yet Recruiting
Tianjin Medical University Cancer Institute and Hospital Hexi District, Tianjin China Not Yet Recruiting
Jiamusi Cancer Hospital Jiamusi China Not Yet Recruiting
Shandong University - Shandong Cancer Hospital Jinan China Not Yet Recruiting
Lin Yi Cancer Hospital Linyi China Not Yet Recruiting
Shanghai East Hospital Shanghai China Not Yet Recruiting
Taizhou Hospital of Zhejiang Province Taizhou China Not Yet Recruiting
Hubei Cancer Hospital Wuhan China Not Yet Recruiting
Henan Provincial Cancer Hospital Zhengzhou China Not Yet Recruiting
Aphm - Hopital Nord Marseille France Not Yet Recruiting
Centre Hospitalier Universitaire de Montpellier (Chu Montpellier) - Hopital Lapeyronie Montpellier France Not Yet Recruiting
Hospitalier Paris Saint-Joseph Paris France Not Yet Recruiting

+ 36 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07739966 on ClinicalTrials.gov ↗ ← All trials in France