Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
Study NCT ID:
NCT06826768
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-02-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-01092 | OTHER | NCI-CTRP Clinical Trials Registry | View |