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)
- October 7, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (22)
Duarte Cancer Center
Duarte, United States
Lennar Foundation Cancer Center
Irvine, United States
UCI Health Chao Family Comprehensive Cancer Center
Orange, United States
Investigational Site Number: 403
Palo Alto, United States
Chicago Cancer Center
Zion, 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
ES34007
Barcelona, Spain
ES34010
Logroño, Spain
Investigational Site Number: 254
Madrid, Spain
Investigational Site Number: 252
Madrid, Spain
ES34012
Madrid, Spain
ES34013
Málaga, Spain
Investigational Site Number: 253
Pamplona, Spain
ES34009
Valencia, Spain
GB44003
Leicester, United Kingdom
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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