RecruitingPhase IMale onlyEN originalProstate cancerMetastatic / advanced

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

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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