First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
NCT ID: NCT05875168
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
540 participants
INTERVENTIONAL
2023-08-18
2027-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation (Part 1)
Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a.
DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Dose Expansion (Part 2)
Multiple expansion cohorts targeting various advanced solid tumors.
DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Interventions
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DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Eligibility Criteria
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Inclusion Criteria
* 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.
* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.
* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.
* Is able to provide either of the following baseline tumor samples:
* 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
* Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual)
* 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 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 a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
* 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, known, or suspected autoimmune disease.
* Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Florida Cancer Specialists
Sarasota, Florida, United States
Oregon Health & Science University
Portland, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
The Medical College of Wisconsin, INC
Milwaukee, Wisconsin, United States
UZ Leuven
Leuven, , Belgium
McGill University Health Center
Montreal, , Canada
Princess Margaret Cancer Center
Toronto, , Canada
Beijing Cancer Hospital
Beijing, , China
Shandong Cancer Hospital
Jinan, , China
The Second Peoples Hospital of Neijiang
Neijiang, , China
Shanghai East Hospital
Shanghai, , China
Centre Léon Bérard
Lyon, , France
Assistance Publique- de Marseille
Marseille, , France
Chu Strasbourg
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
National Cancer Center Hospital
Chūōku, , Japan
Kansai Medical University Hospital
Hirakata-shi, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
Cancer Institute Hospital of Jfcr
Kōtoku, , Japan
Kindai University Hospital
Ōsaka-sayama, , Japan
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Next Madrid
Pozuelo de Alarcón, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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Central Contacts
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(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information
Role: CONTACT
Facility Contacts
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Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
See Central Contact
Role: primary
Principal Investigator
Role: primary
See Central Contact
Role: primary
References
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Takano K, Yukiura M, Takahashi K, Kitamura M, Okuno H, Shiose Y, Honda K, Oyama K, Yamada M, Obuchi W, Kumagai K, Sakurai K, Goto R, Zembutsu A, Kagari T, Abe Y, Agatsuma T. DS-3939a: A TA-MUC1-Directed Antibody-Drug Conjugate with Broad Antitumor Activity. Mol Cancer Ther. 2026 Jan 2;25(1):7-20. doi: 10.1158/1535-7163.MCT-24-0666.
Other Identifiers
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DS3939-077
Identifier Type: -
Identifier Source: org_study_id
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