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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

Call 813-745-6100
or 1-800-679-0775
Overview

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

Inclusion Criteria

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
  • Metastatic, castration-resistant prostate cancer (mCRPC) that has progressed within 6 months prior to screening
  • Has received ≥2 lines of approved systemic therapy for mCRPC, including a second -generation hormonal agent
  • Adequate organ and bone marrow function

  • Exclusion Criteria

  • Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities
  • Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy
  • Has received prior PSMA-targeting therapy
  • Dose Expansion Only: Has had prior anti-cancer immunotherapy
  • Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  • Encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study therapy
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency
  • NOTE: Other protocol defined Inclusion/Exclusion Criteria apply