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Study identifier: NCT05997615 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Hormone-refractory Prostate Cancer  ·  Sponsor: Vir Biotechnology, Inc.

PhasePhase 1
Planned participants437
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

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

This description comes directly from the study's public registry record.

Talk to the study team

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

Always discuss trial participation with your own doctor first.

Locations (12)

Investigational Site Number: 403Palo Alto, California, United StatesRecruiting
Investigational Site Number: 401Houston, Texas, United StatesRecruiting
Investigational Site number: 404Fairfax, Virginia, United StatesRecruiting
Investigational Site Number: 400Seattle, Washington, United StatesRecruiting
Investigational Site Number: 100Melbourne, AustraliaRecruiting
Investigational Site Number: 101Sydney, AustraliaRecruiting
Investigational Site Number: 251Barcelona, SpainWithdrawn
Investigational Site Number: 250Barcelona, SpainRecruiting
Investigational Site Number: 254Madrid, SpainRecruiting
Investigational Site Number: 252Madrid, SpainRecruiting
Investigational Site Number: 253Pamplona, SpainRecruiting
Investigational Site Number: 300London, United KingdomRecruiting

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Source record: clinicaltrials.gov/study/NCT05997615