A Phase Ib Clinical Trial to Optimize Risk Benefit of REGN5678 (PSMAxCD28 Bispecific Antibody) Plus Cemiplimab (Anti-PD-1 Monoclonal Antibody) in Patients With Metastatic Castration-resistant Prostate Cancer
M.D. Anderson Cancer Center
Summary
A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab
Description
Primary Objectives: * To evaluate the safety and tolerability of REGN5678 (PSMAxCD28 bispecific antibody) plus cemiplimab (anti-PD-1) in patients with mCRPC. * To determine the maximum tolerated dose or potential recommended phase II dose (RP2D) of REGN5678 (PSMAxCD28 bispecific antibody) plus cemiplimab (anti-PD-1) in patients with mCRPC Secondary Objectives: * To evaluate efficacy of REGN5678 plus cemiplimab in patients with mCRPC. * To characterize the PK of REGN5678 alone and in combination with cemiplimab * To assess the immunogenicity of REGN5678 and cemiplimab. Exploratory Objective…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Men .18 years of age. 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma. 3. mCRPC with disease progression after at least two lines of systemic therapy, including one line of second-generation anti-androgen therapy, according to one of the following criteria: 1. PSA progression as defined by a rising PSA level confirmed with an interval of \>1 week between each assessment. 2. Radiographic disease progression in soft tissue based on RECIST Version 1.1 criteria with PCWG3 modifications with or without PSA…
Interventions
- DrugREGN5678
Given by IV infusion
- DrugCemiplimab
Given by IV infusion
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas