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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

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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: 18 May 2026

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At a glance

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

Most Recent Events

  • 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.
  • 13 Apr 2026 According to Vir Biotechnology media release, first patient has been dosed in the monotherapy expansion cohort in this trial, which is the first to begin enrollment based on the monotherapy dose-escalation data. The dose regimen to be evaluated in this cohort is Q3W 800/2000/3500 µg/kg step-up dosing.

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