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 (36)
Facility
City
Region
Status
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
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.
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