Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies

Phase 2 Recruiting 40 enrolled M.D. Anderson Cancer Center Regeneron Pharmaceuticals · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).

Timeline

Start: 2024-10-09
Primary completion: 2028-07-31
Completion: 2028-07-31

Publications

Connolly DM, Revon-Riviere G, Chami R, Mills D, Coblentz AC, Uldrick TS, Knorr DA, Goncalves P, Dobosz M, Jalal S, Cohen-Gogo S, Morgenstern DA. Mucin 16-Directed Therapy in Pediatric Sarcomas: Case Evidence of Ubamatamab Efficacy in Epithelioid Sarcoma and Its Implications for Other Sarcoma Subtypes. JCO Precis Oncol. 2025 Aug;9:e2500404. doi: 10.1200/PO-25-00404. Epub 2025 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cemiplimab	Monoclonal antibody	—	Intravenous
Subject	Ubamatamab	Monoclonal antibody	—	Intravenous

Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies

Summary

Timeline

Publications

Drugs

Indications