Clinical Trials in South Korea / 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 South Korea tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Daiichi Sankyo trials in South Korea
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 South Korea