First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
- Advanced Solid Tumor
- Metastatic Solid Tumor
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Daiichi Sankyo
- Enrolment target
- 590
- Started
- 18 August 2023
- Main results due
- 20 October 2026
- Study sites
- 61
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.What this study is about
In the sponsor’s own words, from the registry.
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Study sites(61)
Florida Cancer Specialists
Sarasota, Florida, United States
Withdrawn
Florida Cancer Specialists
Sarasota, Florida, United States
Recruiting
Piedmont Cancer Institute
Locust Grove, Georgia, United States
Withdrawn
University of Kansas Medical Center
Westwood, Kansas, United States
Recruiting
Henry Ford Health System
Detroit, Michigan, United States
Withdrawn
Astera Cancer Care
East Brunswick, New Jersey, United States
Recruiting
Icahn School of Medicine Mt Sinai
New York, New York, United States
Withdrawn
Oregon Health & Science University
Portland, Oregon, United States
Recruiting
Rhode Island Hospital
Providence, Rhode Island, United States
Recruiting
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Withdrawn
The Medical College of Wisconsin, INC
Milwaukee, Wisconsin, United States
Recruiting
The Medical College of Wisconsin, INC
Milwaukee, Wisconsin, United States
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
National Cancer Center Hospital East
Kashiwa, Japan
Recruiting
Cancer Institute Hospital of Jfcr
Kōtoku, Japan
Recruiting
Saiseikai Kumamoto Hospital
Kumamoto, Japan
Recruiting
Osaka International Cancer Institute
Osaka, Japan
Recruiting
Kindai University Hospital
Ōsaka-sayama, Japan
Recruiting
Nho Hokkaido Cancer Center
Sapporo, Japan
Recruiting
Sendai Kousei Hospital
Sendai, Japan
Recruiting
Shizuoka Cancer Center
Sunto-gun, Japan
Recruiting
National Cancer Center
Goyang, South Korea
Recruiting
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Withdrawn
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 12 de Octubre
Madrid, Spain
Withdrawn
Hospital Universitario La Paz
Madrid, Spain
Recruiting
Hospital Regional Universitario de Malaga
Málaga, Spain
Recruiting
Next Madrid
Pozuelo de Alarcón, Spain
Recruiting
Showing 60 of 61 sites — filter to narrow it down. 43 of the 61 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05875168. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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