OncoMatch/Clinical Trials/NCT05997615
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Is NCT05997615 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including VIR-5500 and Enzalutamide for hormone-refractory prostate cancer.
Treatment: VIR-5500 · Enzalutamide · Darolutamide — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Prior therapy
Must have received: androgen-signaling inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide
Must have received: taxane (docetaxel, cabazitaxel)
Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel)
Must have received: PSMA-targeted radiopharmaceutical therapy (177Lu-PSMA-617)
Must have received standard-of-care radioligand-based therapies, including PSMA-targeted radiopharmaceutical therapy, such as 177Lu-PSMA-617
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Investigational Site Number: 400 · Seattle, Washington
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