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Contact Information:

Study Inquiry 415-654-5281
clinicaltrials@vir.bio


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Be Part of Research - Trial Details - Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
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Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

Recruiting

Open to: MALE

Age: 18.0 - N/A

London

Medical Conditions

Hormone-refractory Prostate Cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a).

* Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation * Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion * Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation

o Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) (enzalutamide or darolutamide) * Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion o Part 4a (Combination Dose Expansion): VIR-5500 in combination with an ARSI (enzalutamide or darolutamide)

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2023 Sep 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion

Intervention Arm Group : Part 1: VIR-5500 Monotherapy Dose Escalation;Part 2: VIR-5500 Monotherapy Dose Expansion;

Intervention Type : COMBINATION_PRODUCT
Intervention Description : Oral administration

Intervention Arm Group : Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation;Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion;

Intervention Type : COMBINATION_PRODUCT
Intervention Description : Oral administration

Intervention Arm Group : Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation;Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational Site Number: 300
    London
    SM2 5PT

Study Inquiry 415-654-5281
clinicaltrials@vir.bio



The study is sponsored by Vir Biotechnology, Inc.




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Read full details for Trial ID: NCT05997615
Last updated 23 February 2026

This page is to help you find out about a research study and if you may be able to take part

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