NCT05997615

Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Duration of the study up to approximately 48 months.

Conditions

• Hormone-refractory Prostate Cancer

Interventions

Type	Name	Description
DRUG	VIR-5500	Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
COMBINATION_PRODUCT	Enzalutamide	Oral administration
COMBINATION_PRODUCT	Darolutamide	Oral administration

Timeline

• Start date: 2023-08-10
• Primary completion: 2027-09-29
• Completion: 2027-09-29
• First posted: 2023-08-18
• Last updated: 2026-02-24

Locations

9 sites across 4 countries: United States, Australia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study