Overview

REGN4336 (a PSMAXCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Adult Male Patients With Metastatic Castration-Resistant Prostate Cancer

Status:
Not yet recruiting

Trial end date:
2026-08-04

Target enrollment:

Participant gender:

Summary

The primary objective of the study is: Dose Escalation: • To assess the safety, tolerability, and pharmacokinetics (PK) and to determine recommended phase 2 dosing regimen (RP2DR) of REGN4336 separately as monotherapy or in combination with cemiplimab Dose Expansion: • To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by objective response rate (ORR) per modified Prostate Cancer Working Group (PCWG3) criteria The secondary objectives of the study are: Dose Escalation: • To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by ORR per modified PCWG3 criteria Dose Expansion: - To characterize the safety profile in each expansion cohort - To characterize the PK of REGN4336 as monotherapy or in combination with cemiplimab In both Dose Escalation and Dose Expansion: - To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by prostate specific antigen (PSA) decline - To evaluate immunogenicity of REGN4336 in Module 1 and immunogenicity of REGN4336 and cemiplimab in Module 2

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Regeneron Pharmaceuticals

Treatments:

Cemiplimab