drugset / Trial / NCT05252364

A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT05252364 ↗

Phase 1 Completed 22 enrolled Hinova Pharmaceuticals Aus Pty Ltd
Non-randomizedSequentialOpen-labelTreatment

Summary

The overall objective of this Phase 1 study is to evaluate the safety, PK, and anti-tumor activity of 12 weeks of daily oral dosing with HP518 after selecting the RP2D of HP518 based on assessments of multiple dose escalation in patients with progressive mCRPC.

Timeline

Start
2021-12-14
Primary completion
2024-01-22
Completion
2024-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject HP518 Unknown 25 mg Oral
Subject HP518 Unknown 100 mg Oral
Subject HP518 Unknown 200 mg Oral
Subject HP518 Unknown 300 mg Oral
Subject HP518 Unknown 400 mg Oral
Subject HP518 Unknown 500 mg Oral

Indications