eligibility_summary
Phase 1: Advanced FRα+ solid tumors, disease, ECOG 0–1, adequate organ function, controlled CNS mets allowed. Key exclusions: >G1 neuropathy, ocular disease, serious infection, significant cardiac disease, ILD, hypersensitivity, folate supplements. Phase 2: Platinum‑resistant HGSOC/PPC/FT, FRα‑high (Ventana), 1–3 prior lines, measurable, ECOG 0–1. Exclusions: non‑HGSOC, primary platinum‑refractory, prior FRα agents/TAK‑853, wide‑field RT, untreated CNS, cirrhosis, stroke, >G1 neuropathy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: TAK-853 (mirvetuximab soravtansine), an antibody–drug conjugate (ADC). Mechanism: a humanized anti–folate receptor alpha (FRα) IgG1 monoclonal antibody delivers the maytansinoid payload DM4. After FRα binding and internalization, DM4 is released to inhibit tubulin polymerization, disrupting microtubules, causing mitotic arrest and apoptosis (with potential local bystander effect). Targets: FRα-overexpressing epithelial tumor cells—especially high-grade serous ovarian cancer—and the microtubule/mitotic spindle pathway. Dosing: 6 mg/kg IV every 3 weeks in a Phase 1/2, single-arm study in Japan.