New drug combo aims to boost immune attack on Hard-to-Treat prostate cancer

NCT ID NCT06826768

Recruiting now Disease control Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This early-phase trial tests a new two-drug combination for men with metastatic castration-resistant prostate cancer that has progressed after at least two prior treatments. The drugs are REGN5678, which helps immune cells target cancer cells, and cemiplimab, which removes the brakes on the immune system. The main goal is to find the safest dose and understand side effects in 60 participants.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: REGN5678 (a bispecific antibody targeting PSMA and CD28) plus cemiplimab (an anti-PD-1 immunotherapy)
What this could lead to: If successful, this could lead to a more effective and safer combination therapy for advanced prostate cancer that has stopped responding to standard treatments.
What could go wrong: This is an early Phase 1 trial with only 60 participants, so the benefits are uncertain. The combination may cause significant side effects, and it is not yet known if it will improve survival or quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PROSTATE CANCER

Contacts and locations

Locations

The University of Texas M. D. Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States

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