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

• Status: Not yet recruiting
• Trial end date: 2027-07-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo, Inc.

Criteria

Inclusion Criteria:

• Sign and date the 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 urothelial, non-small cell lung, breast, ovarian, or biliary tract cancers, or pancreatic ductal adenocarcinoma, regardless of any molecular subtypes.

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 core needle biopsy samples obtained during the Screening Period, or

• Alternative FFPE tumor tissue samples obtained by biopsy or surgery performed after the completion date of the most recent anticancer therapy regimen and within 6 months before signing the ICF

Exclusion Criteria:

• Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.

• Has spinal cord compression or history of/clinically active central nervous system metastases.

• Has multiple primary malignancies, except adequately resected nonmelanoma 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 human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid viral load and cluster of differentiation 4 count.

• Has evidence of active 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.