OncoMatch/Clinical Trials/NCT05997615
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Is NCT05997615 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including VIR-5500 and ARSI for hormone-refractory prostate cancer.
Treatment: VIR-5500 · ARSI — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Demographics
Prior therapy
Must have received: androgen-signaling inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
Must have received: taxane (docetaxel, cabazitaxel)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Investigational Site Number: 403 · Palo Alto, California
- Investigational Site Number: 401 · Houston, Texas
- Investigational Site number: 404 · Fairfax, Virginia
- Investigational Site Number: 400 · Seattle, Washington
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05997615 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received androgen-signaling inhibitor and taxane.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages