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Patient Guide to Clinical TrialsSafety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Complete Title: A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer
Trial Phase: I
Investigator: Lawrence Fong
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)
Keywords:
- Prostate Cancer
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