A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Recruiting · NCT06155084 · Interventional (participants receive a specific treatment) · Lead sponsor: Hinova Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
HP518 - Dose EscalationHP518 -Dose Expansion
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
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
27 locations listed.
- 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