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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Nov 2025

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At a glance

  • Drugs Cemiplimab (Primary) ; Nezastomig (Primary) ; Nezastomig (Primary) ; REGN 4336 (Primary) ; Piflufolastat F18
  • Indications Adenocarcinoma; Prostate cancer; Renal cell carcinoma
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 15 Oct 2025 Planned End Date changed from 3 Jul 2026 to 15 Nov 2027.
  • 15 Oct 2025 Planned primary completion date changed from 1 Aug 2025 to 15 Nov 2027.
  • 30 Apr 2025 Updated results (data cutoff date: 26 Feb 2024; n=78) reporting safety, new survival and biomarker analysis data presented at the 116th Annual Meeting of the American Association for Cancer Research

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