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Phase 1/2 Study Of REGN4336 (A PSMAXCD3 Bispecific Antibody) Administered Alone Or In Combination With Cemiplimab In Patients With Metastatic Castration-Resistant Prostate Cancer

Protocol No
REGENERON-R4336-ONC-20104
Principal Investigator
Deepak Kilari
Phase
I/II
Summary
This is a phase 1/2, first-in-human (FIH), open-label, multicenter study evaluating safety, tolerability, efficacy, and PK of REGN4336, administered as monotherapy (Module 1) or in combination with cemiplimab (Module 2) in patients with treatment-experienced mCRPC. For inclusion in this study, patients must have received at least 2 approved therapies for metastatic and/or castration resistant disease.
Description
To assess the safety, tolerability, and PK and to determine RP2DR of REGN4336
separately as monotherapy or in combination with cemiplimab.
Participating Institutions
Froedtert Hospital
Status
RESEARCH MANAGER-DTL SIGNOFF