Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab or REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients with Metastatic Castration-Resistant Prostate Cancer

Protocol No

REGENERON-R4336-ONC-20104

Staff Member

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.

Objective

To assess the safety, tolerability, and PK and to determine RP2DR of REGN4336
separately as monotherapy or in combination with cemiplimab.

Study Sites

Froedtert Hospital

Status

OPEN TO ACCRUAL