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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: 12 Sep 2026

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At a glance

  • Drugs Darolutamide (Primary) ; Docetaxel (Primary) ; Enzalutamide (Primary) ; 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

  • 05 Aug 2026 According to a Vir Biotechnology media release, the Company anticipates initiating two additional Phase 1 dose-expansion cohorts, including VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone-sensitive prostate cancer.
  • 05 Aug 2026 According to a Vir Biotechnology media release, The first patients were dosed in three monotherapy cohorts evaluating VIR-5500 in taxane naive metastatic castration-resistant prostate cancer (mCRPC), radioligand therapy naive mCRPC and radioligand therapy exposed mCRPC, and one combination cohort evaluating VIR-5500 in combination with enzalutamide in early-line mCRPC.
  • 05 Aug 2026 According to a Vir Biotechnology media release, this study will help inform pivotal trial design.

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