eligibility_summary
Adults ≥18 with RMC or ES (incl. unclassified medullary RCC) with SMARCB1 loss, CA‑125 ≥70 U/mL or tumor MUC16 H‑score ≥25 (≤12 mo), measurable disease, progression after ≥1 prior line, ECOG 0–1, adequate organs, controlled brain mets allowed, consent/contraception required. Exclude: other recent cancers, prior T‑cell bispecific/MUC16 tx, current/recent therapy or major surgery, unresolved ≥G2 AEs, transplant, active autoimmune (limited exceptions), uncontrolled infections/COVID, high‑dose steroids, cardiac disease/LVEF<50, live vaccines, pregnancy, allergy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II trial testing: 1) Ubamatamab—an IV bispecific T‑cell–redirecting antibody (MUC16×CD3). Mechanism: simultaneously binds MUC16 (CA‑125) on tumor cells and CD3 on T cells to recruit/activate cytotoxic T cells, driving tumor cell lysis, step-up dosing then weekly → every 3 weeks. 2) Cemiplimab—an IV anti–PD‑1 monoclonal antibody (IgG4) checkpoint inhibitor. Mechanism: blocks PD‑1 on T cells to prevent PD‑L1/PD‑L2 inhibitory signaling, sustaining antitumor T‑cell function. Targets/pathways: MUC16 on SMARCB1‑deficient tumor cells (renal medullary carcinoma, epithelioid sarcoma), CD3 on T cells, and the PD‑1/PD‑L1 axis. Strategy: ubamatamab alone, then addition of cemiplimab upon progression or upfront combo after lead‑in. Biomarkers: serum CA‑125 and tumor MUC16 expression.