Trial Identifiers
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Scientific Title
A Phase 1 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer
Commercial Sponsor
Hinova Pharmaceuticals Aus Pty Ltd
Summary
This is an open-label dose escalation and dose expansion study. Part 1 of the study (dose escalation) consists of 6 cohorts. Each cohort will be assigned a different dose level of HP518: either 25mg/d, 50mg/d, 100mg/d, 200mg/d, 300mg/d or 400mg/d. In all cohorts, HP518 will be administered orally, once daily in 28-day cycles. In Part 2 of the study (dose expansion), participants will receive HP518 orally, once daily in 28-day cycles at the highest dosage level with acceptable toxicity (RP2D) based on the data from Part 1 of the study.