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RECRUITING
NCT06155084
PHASE1/PHASE2

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

Sponsor: Hinova Pharmaceuticals Inc.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2023-12-26

Completion Date

2026-09

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

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.

Locations (27)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital Of Xiamen Univeristy

Xiamen, Fujian, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Affiliated Hospital Of Guizhou Medical University

Guiyang, Guizhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Tongji Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Shandong Provincial Hospital

Jinan, Shandong, China

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital Of Xi'An Jiaotong Univeristy

Xi’an, Shanxi, China

Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital Of Sichuan University

Chengdu, Sichuan, China

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

The Second Affiliated Hospital Of Kunming Medical University

Kunming, Yunnan, China

The Affiliated Hospital Of School Of Medicine Of Ningbo University

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China