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Recruiting Phase 1/2

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

NCT05875168 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 1/2
Started
2023-08-18
Last updated
2026-09-29

Condition(s) studied

Advanced Solid TumorMetastatic Solid Tumor

Investigational drug(s) / intervention(s)

DS-3939a

DS-3939a: One IV infusion Q3W on Day 1 of each 21-day cycle

Study summary

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Sign and date the main Informed Consent Form (ICF). * Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment. * Has adequate organ function. * Measurable disease based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status score of 0 or 1. Additional inclusion criteria for Part 1 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors. Additional inclusion criteria for Part 2 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria * Is able to provide either of the following baseline tumor samples: 1. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or * Fresh core needle biopsy sample * Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual. 2. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample. Exclusion Criteria: * Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1. * Has spinal cord compression or clinically active central nervous system metastases. * Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years. * Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. * Has active or uncontrolled human immunodeficiency virus (HIV) infection. * Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection. * Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. * Has an active (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease. * Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.

Primary outcome measure(s)

  • Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a — Approximately 3 months after first dosing
  • Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939a — Up to approximately 31 months
  • Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2) — Up to approximately 31 months
  • PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only) — Up to approximately 31 months

Trial sites (61)

FacilityCityRegionStatus
Florida Cancer Specialists Sarasota Florida Withdrawn
Florida Cancer Specialists Sarasota Florida Recruiting
Piedmont Cancer Institute Locust Grove Georgia Withdrawn
University of Kansas Medical Center Westwood Kansas Recruiting
Henry Ford Health System Detroit Michigan Withdrawn
Astera Cancer Care East Brunswick New Jersey Recruiting
Icahn School of Medicine Mt Sinai New York New York Withdrawn
Oregon Health & Science University Portland Oregon Recruiting
Rhode Island Hospital Providence Rhode Island Recruiting
University of Texas M.D. Anderson Cancer Center Houston Texas Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah Recruiting
Virginia Cancer Specialists Fairfax Virginia Withdrawn
The Medical College of Wisconsin, INC Milwaukee Wisconsin Recruiting
The Medical College of Wisconsin, INC Milwaukee Wisconsin Withdrawn
UZ Leuven Leuven Belgium Recruiting
McGill University Health Center Montreal Canada Withdrawn
Princess Margaret Cancer Center Toronto Canada Recruiting
Beijing Cancer Hospital Beijing China Withdrawn
Jilin Cancer Hospital Changchun China Withdrawn
Hunan Cancer Hospital Changsha China Withdrawn
Sichuan Cancer Hospital Chengdu China Recruiting
Zhejiang Cancer Hospital Hangzhou China Recruiting
Shandong Cancer Hospital Jinan China Recruiting
The First Affiliated Hospital of Nanchang University Nanchang China Recruiting
The Second Peoples Hospital of Neijiang Neijiang China Recruiting
Shanghai East Hospital Shanghai China Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin China Withdrawn
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan China Withdrawn
The First Affiliated Hospital of Xiâ An Jiaotong University Xi'an China Withdrawn
Xiangyang Central Hospital Xiangyang China Recruiting
Centre Léon Bérard Lyon France Recruiting
Centre Léon Bérard Lyon France Withdrawn
Assistance Publique- de Marseille Marseille France Recruiting
Ico - Site René Gauducheau Saint-Herblain France Recruiting
Chu Strasbourg Strasbourg France Withdrawn
Institut Claudius Regaud Toulouse France Recruiting
Institut Claudius Regaud Toulouse France Recruiting
Institut Gustave Roussy Villejuif France Recruiting
National Cancer Center Hospital Chūōku Japan Recruiting
Kansai Medical University Hospital Hirakata-shi Japan Recruiting

+ 21 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 NCT05875168 on ClinicalTrials.gov ↗ ← All trials in South Korea