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Study of DS-3939a for Advanced Solid Tumors

This study is testing a new drug called DS-3939a in people with advanced solid tumors (cancers that have spread). DS-3939a is an antibody drug conjugate (ADC), which is a type of drug that targets cancer cells. The main goals are to see how safe DS-3939a is, what side effects it causes, and how well it works to shrink tumors. You might be able to join if you are 18 or older, have good heart and organ function, and your cancer can be measured. The study is currently recruiting up to 590 participants, but its overall status is unclear.

Study design
This is a first-in-human study with two parts: a dose escalation part and a dose expansion part. It is an interventional study, meaning participants will receive the study drug.
What's involved
You would receive DS-3939a as an IV infusion every three weeks on Day 1 of each 21-day cycle. You would also have tests to check your heart and organ function.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to approximately 31 months after treatment. Tumor response will also be measured for up to approximately 31 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05875168

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Daiichi Sankyo
~590 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:DS-3939a

At a glance

Recruiting sites
32 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a
Measured over Approximately 3 months after first dosing
+3 more outcomes measured

Conditions

Advanced Solid Tumor
Metastatic Solid Tumor

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Solid Neoplasm

NCT05875168

Where you'd take part

This study runs at 36 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Assistance Publique- de Marseille

    Marseille, Franceno site contact published

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Chinano site contact published

    Not yet recruiting

  • Cancer Institute Hospital of Jfcr

    Kōtoku, Japanno site contact published

    Recruiting

  • Centre Léon Bérard

    Lyon, Franceno site contact published

    Recruiting

  • Chu Strasbourg

    Strasbourg, Franceno site contact published

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Floridano site contact published

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, Spainno site contact published

    Recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, Spainno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo

Who to contact

(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
[email protected]
908-992-6400
Email the study team

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Eligibility criteria

Inclusion

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
Is able to provide either of the following baseline tumor samples:
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

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 trial measures

  • Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939aApproximately 3 months after first dosing
  • Overall Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events Following Treatment With DS-3939aUp to approximately 31 months
  • Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2)Up to approximately 31 months
  • PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only)Up to approximately 31 months