REGN5678 + Cemiplimab for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBilal Siddiqui, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?A single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab

Eligibility Criteria

This trial is for men aged 18+ with advanced prostate cancer (mCRPC) that has worsened after at least two systemic therapies, including anti-androgen therapy. Participants must have adequate organ function, no active infections like HIV or hepatitis, and an ECOG performance status of 0 or 1. They should not be in other trials, have certain other cancers or severe health conditions, and must agree to use contraception.

Inclusion Criteria

My prostate cancer has worsened after two treatments, including a newer hormone therapy.

My blood tests show normal hemoglobin, neutrophil, and platelet levels.

My kidney function is within the normal range.

+9 more

Exclusion Criteria

Currently receiving treatment in another interventional study

Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study

Has participated in a study of an investigational drug within 4-weeks of first dose of study therapy

+14 more

Participant Groups

The study tests REGN5678 combined with Cemiplimab in a phase Ib/II trial involving dose escalation and expansion. It's designed to see how well these drugs work together for patients who've already tried multiple treatments for mCRPC.

1Treatment groups

Experimental Treatment

Group I: Treatment with REGN5678 Q3W IV + Cemiplimab Q3W IVExperimental Treatment2 Interventions

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).