Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing REGN5678 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab.

Official registry: https://clinicaltrials.gov/study/NCT03972657 · Regeneron Pharmaceuticals · enrollment listed as 345

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are REGN5678, or Cemiplimab. The registry lists allocation as randomized. The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.

They plan to enroll about 345 people at 27 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression

Interventions: REGN5678, Cemiplimab

Primary outcome (registry wording): Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • mCRPC cohorts (men):
  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
  • PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol
  • Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy \[ADT\]) including at least:
  • one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
  • 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol
  • ccRCC cohorts (men and women):

Public study contact (from the registry)

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

27 listed

+ 3 sites outside the US on the same record

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FAQ about this NCT record

Is NCT03972657 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03972657?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03972657?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary