Testing DS-3939a for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, and efficacy of DS-3939a, an antibody drug conjugate, in participants with advanced solid tumors. The study is divided into two parts: a dose escalation phase to determine the optimal dosage and a dose expansion phase to further assess its effectiveness. Participants will be monitored for their response to the treatment and any side effects experienced during the trial.

Why it matters

Who can join: the full rules

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

  1. 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.
  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 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 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's running

• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• University of Kansas Medical Center
  Westwood, Kansas, United States Recruiting
• Astera Cancer Care
  East Brunswick, New Jersey, United States Recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Recruiting
• Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting
• University of Texas M.D. Anderson Cancer Center
  Houston, Texas, United States Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
• Email: CTRinfo@dsi.com
• Phone: 908-992-6400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.