🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05875168
Recruiting Phase 1/2

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

NCT05875168 · tracked via the Priya Life Science China tracker
Sponsor
Daiichi Sankyo
Phase
Phase 1/2
Started
2023-08-18
Last updated
2026-08-12

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)

Trial sites (36)

FacilityCityRegionStatus
Florida Cancer Specialists Sarasota Florida Recruiting
University of Kansas Medical Center Westwood Kansas Recruiting
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
The Medical College of Wisconsin, INC Milwaukee Wisconsin Recruiting
UZ Leuven Leuven Belgium Recruiting
McGill University Health Center Montreal Canada Not Yet Recruiting
Princess Margaret Cancer Center Toronto Canada Active Not Recruiting
Beijing Cancer Hospital Beijing China Not Yet Recruiting
Shandong Cancer Hospital Jinan China Recruiting
The Second Peoples Hospital of Neijiang Neijiang China Recruiting
Shanghai East Hospital Shanghai China Recruiting
Centre Léon Bérard Lyon France Recruiting
Assistance Publique- de Marseille Marseille France Recruiting
Chu Strasbourg Strasbourg 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
National Cancer Center Hospital East Kashiwa Japan Recruiting
Cancer Institute Hospital of Jfcr Kōtoku Japan Recruiting
Osaka International Cancer Institute Osaka Japan Recruiting
Kindai University Hospital Ōsaka-sayama Japan Recruiting
Sendai Kousei Hospital Sendai Japan Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Withdrawn
Samsung Medical Center Seoul South Korea Recruiting
Hospital Universitari Vall D'Hebron Barcelona Spain Recruiting
Hospital Universitario Ramon Y Cajal Madrid Spain Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Hospital Regional Universitario de Malaga Málaga Spain Recruiting
Next Madrid Pozuelo de Alarcón Spain Recruiting
Hospital Universitario Virgen Macarena Seville Spain Recruiting

More Daiichi Sankyo trials in China

Other trials for the same condition

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 China