Back to search results

REGN5678 and Cemiplimab for Metastatic Prostate Cancer

This study is testing a new combination of two drugs, REGN5678 and cemiplimab, for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and no longer responds to standard hormone therapy. You may be able to join if you are at least 18 years old and your prostate cancer has progressed after at least two other treatments, including a specific type of anti-androgen therapy. The main goal of this study is to understand the safety and side effects of this drug combination. Researchers also want to find the best dose to use in future studies. This study is currently enrolling about 60 participants.

Study design
This is a Phase Ib/II study to find the best dose and evaluate the safety and effectiveness of REGN5678 plus cemiplimab. It is a single-center study.
What's involved
You would receive REGN5678 and cemiplimab through an IV infusion. The study will measure safety and side effects for about one year.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06826768

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~60 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:REGN5678Cemiplimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs
Measured over Through study completion; an average of 1 year.

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Bilal Siddiqui, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Bilal Siddiqui, MD
[email protected]
(713) 563-4600
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Myocardial infarction or unstable angina .6 months prior to treatment initiation
Clinically significant cardiac arrhythmia
Deep vein thrombosis, pulmonary embolism, stroke .6 months prior to treatment initiation
Congestive heart failure (New York Heart Association class III-IV)
Pericarditis/clinically significant pericardial effusion
Myocarditis 12. Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) .2 years prior to enrollment. 13. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \[ADLs\]) or uncontrolled seizures in the year prior to first dose of study therapy. 14. Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years). 15. Receipt of a live vaccine within 4 weeks of planned start of study medication. 16. Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment. 17. Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study.

What this trial measures

  • Safety and Adverse Events (AEsThrough study completion; an average of 1 year.

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0