RecruitingPhase 1NCT05997615

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

A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer


Sponsor

Vir Biotechnology, Inc.

Enrollment

390 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called VIR-5500 (also known as AMX-500) in men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments. **You may be eligible if...** - You have prostate cancer that has spread (metastatic) and is no longer responding to hormone-lowering treatments (called castration-resistant prostate cancer or mCRPC) - You have already tried at least one hormone-blocking drug (such as enzalutamide, abiraterone, apalutamide, or darolutamide) - You have already received at least one chemotherapy regimen using drugs like docetaxel or cabazitaxel - Your doctor has determined that standard treatments are no longer suitable for you - Some parts of the study also require prior treatment with a radioactive PSMA-targeted therapy (such as lutetium-177 PSMA) **You may NOT be eligible if...** - You have not yet tried standard second-line hormone therapies or taxane-based chemotherapy - Your cancer has not been confirmed to be progressing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVIR-5500

Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion

COMBINATION_PRODUCTEnzalutamide

Oral administration

COMBINATION_PRODUCTDarolutamide

Oral administration


Locations(10)

Investigational Site Number: 401

Houston, Texas, United States

Investigational Site Number: 400

Seattle, Washington, United States

Investigational Site Number: 100

Melbourne, Australia

Investigational Site Number: 101

Sydney, Australia

Investigational Site Number: 251

Barcelona, Spain

Investigational Site Number: 250

Barcelona, Spain

Investigational Site Number: 254

Madrid, Spain

Investigational Site Number: 252

Madrid, Spain

Investigational Site Number: 253

Pamplona, Spain

Investigational Site Number: 300

London, United Kingdom

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NCT05997615