Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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)
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Przerzuty raka widoczne w badaniach obrazowych (tomografia, rezonans magnetyczny lub scyntygrafia kostna)
- •Rak prostaty oporny na hormonотerapię z potwierdzonym postępem choroby
- •Wcześniejsze leczenie lekami hormonalnymi (abiraterone, apalutamide, darolutamide lub enzalutamide)
- •Wcześniejsze leczenie chemioterapią zawierającą taksany (docetaxel lub cabazitaxel)
- •Nienadający się do standardowego leczenia według opinii lekarza
- •Możliwość udziału pacjentów z rakiem prostaty wrażliwym na hormony lub po recydywie biochemicznym
✗ Disqualifies
- •Szczególne typy histologiczne raka (sarcomatoid, vrzecionowate lub drobiazgokomórkowe)
- •Aktywne infekcje ostre lub przewlekłe
- •Stany zdrowotne mogące zwiększyć ryzyko działań niepożądanych leku
- •Przerzuty blisko ważnych narządów
- •Przerzuty do mózgu lub opon mózgowych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 24, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (12)
Investigational Site Number: 403
Palo Alto, United States
Investigational Site Number: 401
Houston, United States
Investigational Site number: 404
Fairfax, United States
Investigational Site Number: 400
Seattle, 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
Trial contact
Study Inquiry
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/25/2026.
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