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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor

In brief

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

Key facts

Study ID

NCT05875168

Run by

Daiichi Sankyo

People needed

590

Starts

2023-08-18

Expected to finish

2027-02-15

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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:
• 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.
• 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 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.

Where it is running

• Hospital Universitario Virgen Macarena — Seville, Spain (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (enrolling)
• The Medical College of Wisconsin, INC — Milwaukee, Wisconsin, United States (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• Next Madrid — Pozuelo de Alarcón, Spain (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Princess Margaret Cancer Center — Toronto, Canada (enrolling)
• Shandong Cancer Hospital — Jinan, China (enrolling)
• The Second Peoples Hospital of Neijiang — Neijiang, China (enrolling)
• Shanghai East Hospital — Shanghai, China (enrolling)
• Centre Léon Bérard — Lyon, France (enrolling)
• Assistance Publique- de Marseille — Marseille, France (enrolling)
• Chu Strasbourg — Strasbourg, France (enrolling)
• Institut Claudius Regaud — Toulouse, France (enrolling)
• Institut Gustave Roussy — Villejuif, France (enrolling)
• National Cancer Center Hospital — Chūōku, Japan (enrolling)
• Kansai Medical University Hospital — Hirakata-shi, Japan (enrolling)
• National Cancer Center Hospital East — Kashiwa, Japan (enrolling)
• Cancer Institute Hospital of Jfcr — Kōtoku, Japan (enrolling)
• Kindai University Hospital — Ōsaka-sayama, Japan (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital, Yonsei University Health System — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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