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

NCT05875168 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DS3939-077
• Study Type: interventional
• Target: 540
• Locations: 8 countries
• Sites: 33

Brief Summary

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

DS-3939a; anti-body drug conjugate; advanced/metastatic solid tumors

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (13)

• Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 1)

  Up to approximately 31 months

• Disease Control Rate Following Treatment With DS-3939a

  Up to approximately 31 months

• Duration of Response Following Treatment With DS-3939a

  Up to approximately 31 months

• Time to Response Following Treatment With DS-3939a

  Up to approximately 31 months

• Progression Free Survival Following Treatment With DS-3939a

  Up to approximately 31 months

Study Arms (2)

Dose Escalation (Part 1)

EXPERIMENTAL

Participants with locally advanced, metastatic, or unresectable tumors who will receive an intravenous (IV) infusion of DS-3939a.

Drug: DS-3939a

Dose Expansion (Part 2)

EXPERIMENTAL

Multiple expansion cohorts targeting various advanced solid tumors.

Drug: DS-3939a

Interventions

DS-3939a DRUG

One IV infusion Q3W on Day 1 of each 21-day cycle

Dose Escalation (Part 1); Dose Expansion (Part 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (33)

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

The Medical College of Wisconsin, INC

Milwaukee, Wisconsin, 53226, United States

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

McGill University Health Center

Montreal, H4A 3J1, Canada

NOT YET RECRUITING

Princess Margaret Cancer Center

Toronto, M5G2M9, Canada

RECRUITING

Beijing Cancer Hospital

Beijing, 100142, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, 250117, China

RECRUITING

The Second Peoples Hospital of Neijiang

Neijiang, 641000, China

RECRUITING

Shanghai East Hospital

Shanghai, 200120, China

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Assistance Publique- de Marseille

Marseille, 13005, France

RECRUITING

Chu Strasbourg

Strasbourg, 67091, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

National Cancer Center Hospital

Chūōku, 104-0045, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata-shi, 573-1191, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

RECRUITING

Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550, Japan

RECRUITING

Kindai University Hospital

Ōsaka-sayama, 589-8511, Japan

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, 8035, Spain

RECRUITING

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

RECRUITING

Next Madrid

Pozuelo de Alarcón, 28223, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 40635151 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Central Study Contacts

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400; CTRinfo@dsi.com

(Asia Sites) Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

+81-3-6225-1111 (M-F 9-5 JST); dsclinicaltrial@daiichisankyo.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 25, 2023
• Study Start: August 18, 2023
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

KR (4); CA (2); BE (1); FR (5); US (6); CN (4); ES (6); JP (5)