Clinical Trial 24204

• Overview

  Study Title:

  Phase 1/2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination with Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients with Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma

  Summary:

  This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells.

  Objective:

  Primary Objectives Dose escalation: To assess the safety, tolerability, and to determine the RP2D range. Dose expansion: To assess preliminary anti-tumor activity. Secondary Objectives: Dose escalation: To assess preliminary anti-tumor activity. Dose expansion: To characterize the safety profile of REGN15505 in each expansion cohort. Dose escalation: To assess preliminary anti-tumor activity using PSA-specific measures for participants with mCRPC Dose expansion: To assess preliminary anti-tumor activity using PSA-specific measures for participants with mCRPC Dose escalation: To characterize the PK of REGN15505 in each module Dose expansion: To characterize the PK of REGN15505 in each module Dose escalation: To assess the immunogenicity of REGN15505 and REGN4336 Dose expansion: To assess the immunogenicity of REGN15505 and REGN4336

• Treatments

  Therapies:

  Bispecific Antibody bridging PSMA with CD3+; Bispecific Antibody targeting PSMA and 4-1BB; Monoclonal anti-PD-1 Antibody

  Medications:

  Cemiplimab (); REGN15505 (); REGN2810 (Cemiplimab); REGN4336 ()

• Inclusion Criteria

  Key Inclusion Criteria: Participants with mCRPC:
  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
  • mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
  • Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
  • Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone > Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
  • Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
  • Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)/ Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and/or a Tyrosine Kinase Inhibitor (TKI)
  • Other criteria may apply

• Exclusion Criteria

  Key Exclusion Criteria: For Both mCRPC and ccRCC Cohorts:
  • Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol mCRPC Cohort Only:
  • Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617)
  • Other protocol defined inclusion/exclusion criteria apply

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