Actively Recruiting
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Led by Hinova Pharmaceuticals Inc. · Updated on 2025-12-22
84
Participants Needed
27
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, age 18 years or older
- Patients with androgen receptor ligand binding domain activation mutations (for dose expansion part)
- Histologically confirmed adenocarcinoma of the prostate without significant neuroendocrine differentiation or small cell characteristics
- Metastatic disease documented by 2 or more bone lesions or soft tissue progression by CT/MRI at study start
- Disease progression after at least one new endocrine therapy and first-line chemotherapy
- Recovery from toxicities related to prior treatments
- Ongoing androgen deprivation therapy with LHRH agonist/antagonist or history of bilateral orchiectomy
- ECOG performance status of 0 to 1
You will not qualify if you...
- Use of research or commercially available drugs targeting androgen receptor
- Any anticancer treatments including immunotherapy, chemotherapy, or radiotherapy within 4 weeks prior to first dose of HP518
- Gastrointestinal disorders affecting absorption (e.g., gastrectomy)
- Significant cardiovascular disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 27 locations
1
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
4
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
6
The First Affiliated Hospital Of Xiamen Univeristy
Xiamen, Fujian, China
Not Yet Recruiting
7
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Actively Recruiting
8
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
9
The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
10
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
11
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Actively Recruiting
12
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
13
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
14
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
15
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Actively Recruiting
16
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
17
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
18
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Actively Recruiting
19
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
20
The First Affiliated Hospital Of Xi'An Jiaotong Univeristy
Xi’an, Shanxi, China
Actively Recruiting
21
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
22
West China Hospital Of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
23
The Affiliated Hospital Of Southwest Medical University
Luzhou, Sichuan, China
Actively Recruiting
24
Mianyang Central Hospital
Mianyang, Sichuan, China
Actively Recruiting
25
The Second Affiliated Hospital Of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
26
The Affiliated Hospital Of School Of Medicine Of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
27
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Q
Qianrong Xiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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