Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT06826768
Brief Summary:
A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab
Detailed 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:
• To evaluate immune responses in the prostate TME and peripheral blood after treatment with REGN5678 plus cemiplimab as compared to pre-treatment samples.
Study:
NCT06826768
Study Brief:
Protocol Section:
NCT06826768