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A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Sponsor: Hinova Pharmaceuticals Inc.
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
HP518 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
HP518 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
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