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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 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. The trial reports 9 study locations across 2 states.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05997615
The ClinicalTrials.gov registry entry for NCT05997615 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vir Biotechnology, which has 13 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 2 distinct geographic areas - top geographies include 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.
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