A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06826768
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN5678 — DRUG
    Given by IV infusion
  • Cemiplimab — DRUG
    Given by IV infusion

Study Details

A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab

Key Dates

Start date
Jul 9, 2025
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 1, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with REGN5678 Q3W IV + Cemiplimab Q3W IV
    Patients will receive three weekly doses of REGN5678 as part of a Lead-In Phase and thentransition to every three-week dosing of the combination of REGN5678 and cemiplimab (anti-PD-1).

Primary Outcome Measure

Safety and Adverse Events (AEs [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Bilal Siddiqui, MD
[email protected]
713-563-4600
Bilal Siddiqui, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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