NCT06155084

A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

A Phase I/II Open-Label Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer in China

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Hinova Pharmaceuticals Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide preliminary efficacy for the reference of future studies.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	HP518 - Dose Escalation	Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
DRUG	HP518 - Dose Escalation	Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
DRUG	HP518 -Dose Expansion	Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.

Timeline

• Start date: 2023-12-26
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2023-12-04
• Last updated: 2025-12-22

Locations

27 sites across 1 country: China