A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
NCT ID: NCT06155084
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2023-12-26
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 - Dose Escalation, 400mg/d (Cohort1)
Oral tablet(s), once daily in 28-day cycles
HP518 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
Part 1 - Dose Escalation 500mg/d (Cohort 2)
Oral tablet(s), once daily in 28-day cycles
HP518 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
Part 2 - Dose Expansion Oral tablet(s)
Oral tablet(s), once daily in 28-day cycles
HP518 -Dose Expansion
Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II)
3. Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics.
4. 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.
5. the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy.
6. Must have recovered from toxicities related to any prior treatments
7. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
8. ECOG performance status score of 0 to 1.
Exclusion Criteria
2. 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.
3. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
4. Has significant cardiovascular disease.
18 Years
MALE
No
Sponsors
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Hinova Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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HP518-01-01-03
Identifier Type: -
Identifier Source: org_study_id