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NCT05875168PHASE1, PHASE2Recruiting

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

Daiichi Sankyo

Start Date

8/18/2023

Completion Date

2/15/2027

Summary

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

Detailed Description

DS-3939a is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).

Eligibility Criteria

Age Range: 18 years to No maximum

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 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 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.

Interventions

DRUG

DS-3939a

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Conditions

Advanced Solid TumorMetastatic Solid Tumor

Locations

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas 77030

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah 84112

United States

The Medical College of Wisconsin, INC

Milwaukee, Wisconsin 53226

United States

UZ Leuven

Leuven, 3000

Belgium

McGill University Health Center

Montreal, H4A 3J1

Canada

Princess Margaret Cancer Center

Toronto, M5G2M9

Canada

Beijing Cancer Hospital

Beijing, 100142

China

Shandong Cancer Hospital

Jinan, 250117

China

The Second Peoples Hospital of Neijiang

Neijiang, 641000

China

Shanghai East Hospital

Shanghai, 200120

China

Centre Léon Bérard

Lyon, 69008

France

Assistance Publique- de Marseille

Marseille, 13005

France

Chu Strasbourg

Strasbourg, 67091

France

Institut Claudius Regaud

Toulouse, 31059

France

Institut Gustave Roussy

Villejuif, 94805

France

National Cancer Center Hospital

Chūōku, 104-0045

Japan

Kansai Medical University Hospital

Hirakata-shi, 573-1191

Japan

National Cancer Center Hospital East

Kashiwa, 277-8577

Japan

Cancer Institute Hospital of Jfcr

Kōtoku, 135-8550

Japan

Kindai University Hospital

Ōsaka-sayama, 589-8511

Japan

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hospital Universitari Vall D'Hebron

Barcelona, 8035

Spain

Hospital Universitario Ramon Y Cajal

Madrid, 28034

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Regional Universitario de Malaga

Málaga, 29010

Spain

Next Madrid

Pozuelo de Alarcón, 28223

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain