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NCT05997615 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
A Phase 1 study of Hormone-refractory Prostate Cancer, sponsored by Vir Biotechnology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 390
- Enrollment target
- 9
- Study locations
NCT05997615: Recruiting Phase 1 study of Hormone-refractory Prostate Cancer, sponsored by Vir Biotechnology.
NCT05997615 is a Phase 1 study of Hormone-refractory Prostate Cancer that is actively recruiting participants, run by Vir Biotechnology. The registered enrollment target is 390 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (550% higher). The trial reports 9 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05997615, a Phase 1 study of Hormone-refractory Prostate Cancer, is actively recruiting participants, sponsored by Vir Biotechnology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 390 participants
- Enrollment target
- 9
- Study locations
Study Summary
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)
Primary Outcome
Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Conditions Studied
Interventions
- DRUG VIR-5500
- COMBINATION_PRODUCT Enzalutamide
- COMBINATION_PRODUCT Darolutamide
Study Locations (9)
Other
- Investigational Site Number: 100 - Melbourne
- Investigational Site Number: 101 - Sydney
- Investigational Site Number: 251 - Barcelona
- Investigational Site Number: 250 - Barcelona
- Investigational Site Number: 254 - Madrid
- Investigational Site Number: 252 - Madrid
- Investigational Site Number: 253 - Pamplona
- Investigational Site Number: 300 - London
Washington
- Investigational Site Number: 400 - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2023-08-10 |
| Est. Completion | 2027-09-29 |
| Phase | Phase 1 |
What NCT05997615 shows while recruiting
NCT05997615 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (550% higher).
The record links to 1 condition, with Hormone-refractory Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which VIR-5500 is the first listed.
NCT05997615 lists 9 locations in 2 states (Other, Washington).
Frequently Asked Questions
What is clinical trial NCT05997615 about?
NCT05997615 is a clinical study titled "Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer". 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-5...
What is the current status of trial NCT05997615?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 390 participants. The study started on 2023-08-10. Estimated completion is 2027-09-29.
What conditions does trial NCT05997615 study?
This clinical trial studies the following conditions: Hormone-refractory Prostate Cancer.
What interventions are being tested in trial NCT05997615?
The interventions under investigation include: VIR-5500 (DRUG), Enzalutamide (COMBINATION_PRODUCT), Darolutamide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05997615?
This trial is sponsored by Vir Biotechnology, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05997615 being conducted?
This trial has 9 study locations across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05997615's enrollment target sits among peer trials
390 78th of 2000 higher than 1,923 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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