Under construction – not a live service
Sign in
Taking people in ChinaPhase 1/2

Tests oral HP518 in men with advanced prostate cancer that stopped responding to hormones

Tests daily oral HP518 in adults with metastatic castration-resistant prostate cancer.

Plain-language title generated from the registry record
Registry title: A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

Key facts

Where
Beijing, Changsha, Chengdu, Chongqing, Guangzhou, Guiyang, Hefei, Jinan, Kunming, Lanzhou, Luzhou, Mianyang, Nanchang, Ningbo, Qingdao, Shanghai, Shenyang, Wenzhou, Wuhan, Xi’an, Xiamen, Yantai, and Zhengzhou, ChinaSee the 27 sites
Phase
Phase 1/2

Where in China

  • Beijing Cancer HospitalBeijing, ChinaTaking people
  • Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaTaking people
  • Hunan Cancer HospitalChangsha, ChinaTaking people
  • Sichuan Academy of Medical Science & Sichuan Provincial People's HospitalChengdu, ChinaTaking people
  • West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
  • Chongqing University Cancer HospitalChongqing, ChinaTaking people
  • The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
  • The Third Affiliated Hospital of Southern Medical UniversityGuangzhou, ChinaTaking people
  • The Affiliated Hospital of Guizhou Medical UniversityGuiyang, ChinaTaking people
  • The Second Hospital of Anhui Medical UniversityHefei, ChinaTaking people
  • Shandong Provincial HospitalJinan, ChinaTaking people
  • The Second Affiliated Hospital of Kunming Medical UniversityKunming, ChinaTaking people
  • Lanzhou University Second HospitalLanzhou, ChinaTaking people
  • The Affiliated Hospital of Southwest Medical UniversityLuzhou, ChinaTaking people
  • Mianyang Central HospitalMianyang, ChinaTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
  • The Affiliated Hospital Of School Of Medicine Of Ningbo UniversityNingbo, ChinaTaking people
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaTaking people
  • Shanghai Tenth People's HospitalShanghai, ChinaTaking people
  • Liaoning Cancer Hospital & InstituteShenyang, ChinaTaking people
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
  • Tongji HospitalWuhan, ChinaTaking people
  • The First Affiliated Hospital Of Xi'An Jiaotong UniveristyXi’an, ChinaTaking people
  • The First Affiliated Hospital Of Xiamen UniveristyXiamen, ChinaNot yet recruiting
  • Yantai Yuhuangding HospitalYantai, ChinaTaking people
  • Henan Cancer HospitalZhengzhou, ChinaTaking people
  • Zhengzhou Central HospitalZhengzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Hinova Pharmaceuticals Inc.
Trial code
NCT06155084
Record updated
22 December 2025
Original description
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 phaseRead full original descriptionShow less

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

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

Inclusion: Male, age ≥18; Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II); Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics; Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT/MRI at the beginning of study; the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy; Must have recovered from toxicities related to any prior treatments; Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy; ECOG performance status score of 0 to 1.

Exclusion: Combination of research or commercially available drugs targeting AR; Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518; Has gastrointestinal disorder affecting absorption (e.g., gastrectomy); Has significant cardiovascular disease.

ClinicalTrials.gov NCT06155084