eligibility_summary
Eligibility: Consent, LVEF ≥50%, adequate organs, measurable disease (RECIST 1.1), ECOG 0–1. Part 1: locally advanced/metastatic/unresectable solid tumors. Part 2: same plus radiographic progression and tumor tissue available (fresh biopsy or FFPE ≤6 months). Exclude prior MUC1 therapy, active CNS mets/spinal compression, multiple primaries (except low-risk), ILD/pneumonitis, active/uncontrolled HIV, HBV/HCV, recent arterial events, autoimmune disease, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05875168 tests DS-3939a, a first‑in‑human antibody–drug conjugate (ADC) given IV Q3W. DS-3939a uses a humanized monoclonal antibody that binds tumor‑associated MUC1 (TA‑MUC1) on cancer cell surfaces, upon antigen binding and internalization, the conjugated cytotoxic payload is released intracellularly to kill the TA‑MUC1–expressing cells. Drug type: targeted biologic (ADC). Targeted cells/pathways: epithelial tumor cells overexpressing aberrantly glycosylated MUC1 (TA‑MUC1). The ADC leverages antigen-mediated endocytosis rather than directly inhibiting MUC1 signaling, downstream effect is payload‑driven cytotoxicity in TA‑MUC1–positive advanced/metastatic solid tumors. Phase 1/2 with dose escalation and expansion cohorts.