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A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX-818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

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Trial Profile

A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX-818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 Jan 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; SAR 446309 (Primary)
  • Indications Advanced breast cancer; Colorectal cancer; HER2 positive breast cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Amunix

Most Recent Events

  • 08 Jan 2025 Preliminary safety and efficacy results (n=79) presented in the Vir Biotechnology Media Release.
  • 09 Sep 2024 According to a Vir Biotechnology media release, the exclusive worldwide license agreement with Sanofi announced on August 1, 2024, has closed, providing Vir with an exclusive worldwide license to three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the proprietary PRO-XTENTM masking platform. The clinical-stage assets under the agreement are SAR446309, SAR446329 and SAR446368.
  • 01 Aug 2024 According to a Vir Biotechnology media release, phase 1 monotherapy and combination study data expected in the second half of 2025.

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