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: 08 Dec 2025

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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

05 Nov 2025 According to Vir Biotechnology media release, data update from the trial is planned for the first quarter of 2026
09 Oct 2025 According to Vir Biotechnology media release, the first patient has been dosed in Part 3 of this trial
24 Sep 2025 Planned number of patients changed from 215 to 390.

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