A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer
Vir Biotechnology, Inc.
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)
Description
Duration of the study up to approximately 48 months.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: Applicable to Parts 1 and 2 * Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging * Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) * Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide * Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) * Are deemed unsuitable for standard of care Applicable to Part 2 Cohort 1…
Interventions
- DrugVIR-5500
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
- Combination ProductEnzalutamide
Oral administration
- Combination ProductDarolutamide
Oral administration
Locations (10)
- Investigational Site Number: 401Houston, Texas
- Investigational Site Number: 400Seattle, Washington
- Investigational Site Number: 100Melbourne
- Investigational Site Number: 101Sydney
- Investigational Site Number: 251Barcelona
- Investigational Site Number: 250Barcelona