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Clinical Trial 20117
Cancer Type: Genitourinary
Interventions:Cemiplimab (); REGN2810 (Cemiplimab); REGN5678 ()
Study Type: Treatment
Phase of Study: Phase I/II
Investigators:
- Jingsong Zhang
Study Title
A Phase 1/2 Study of Regn5678 (Anti-psmaxcd28) with Cemiplimab (Anti-pd-1) in Patients with Metastatic Castration-Resistant Prostate Cancer
Summary
The primary objectives of the study in Dose Escalation are to evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab and in Dose Expansion are to assess efficacy, as measured by objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria, of REGN5678 in combination with cemiplimab.
Objective
The primary objectives of the study are: Dose Escalation: To evaluate safety, tolerability, and pharmacokinetics (PK) of REGN5678 alone and in combination with cemiplimab Dose Expansion: To assess efficacy, as measured by objective response rate (ORR) per modified Prostate Cancer Working Group 3 (PCWG3) criteria, of REGN5678 in combination with cemiplimab