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A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies

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Trial Profile

A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Jun 2025

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At a glance

  • Drugs Cemiplimab (Primary) ; Fianlimab (Primary)
  • Indications Cancer; Head and neck cancer; Lymphoma; Malignant melanoma; Squamous cell cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals

Most Recent Events

  • 30 Apr 2025 Results (at the data cutoff Oct 31, 2023) of efficacy analysis by blinded independent central review (BICR)in subgroups of pts with advanced melanoma were presented at the 116th Annual Meeting of the American Association for Cancer Research.
  • 09 Sep 2024 According to a Regeneron Pharmaceuticals media release, company will present two-year results evaluating the investigational combination of LAG-3 inhibitor fianlimab and Libtayo (cemiplimab) in adults with advanced melanoma across three independent expansion cohorts of a first-in-human, multi-cohort trial in European Society for Medical Oncology (ESMO) Annual Meeting (September 13-17).
  • 04 Jun 2024 Results (as of 04 Oct 2023 data cut off)presented at the 60th Annual Meeting of the American Society of Clinical Oncology

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