Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

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NCT05997615 · readout in 405 d

Sponsored by Vir Biotechnology, Inc. (industry) · VIR — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

437estimated

Sites

Countries

Australia, Spain, United Kingdom +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-08-10

actual

When the study began enrolling

Primary completion

2027-09-29

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-09-29

estimated

The whole study's end, after follow-up

First posted

2023-08-18

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-04

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Hormone-refractory Prostate Cancer

Interventions

Drug: VIR-5500
Combination product: ARSI

Primary outcomes

what the primary-completion date above is the date OF

Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs)

measured from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs)

measured from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to Day 21 or Day 28

Part 2 and 4a: Prostate-Specific Antigen (PSA) response rate

measured from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

Part 2 and 4a: Objective Response Rate (ORR)

measured from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

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