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A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer

Trial Profile

A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 12 Jun 2026

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At a glance

  • Drugs VIR 5500 (Primary) ; Androgen receptor antagonists
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms AMX-500-001
  • Sponsors Amunix; Vir Biotechnology

Most Recent Events

  • 04 Jun 2026 Planned number of patients changed from 390 to 437.
  • 06 May 2026 According to a Vir Biotechnology media release, first patient dosed in Phase 1 dose-expansion cohorts in patients with late-line metastatic prostate cancer.
  • 13 Apr 2026 According to Vir Biotechnology media release, dose-escalation of VIR-5500 in combination with enzalutamide is ongoing in early-line mCRPC patients. The Company anticipates dosing of first patients in the combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months.

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