Evaluating a new oral medication for advanced prostate cancer

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

This study is testing a new oral medication for advanced prostate cancer to see if it is safe and effective for patients whose cancer has spread and is resistant to other treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Hinova Pharmaceuticals Inc. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 27 sites (Hefei, Anhui and 26 other locations)
• Trial ID: NCT06155084 on ClinicalTrials.gov

What this trial studies

This Phase I/II study aims to assess the safety, pharmacokinetics, and anti-tumor activity of HP518, an oral medication, in patients with metastatic castration-resistant prostate cancer (mCRPC). The study involves a dose-escalation phase to determine the recommended phase 2 dose (RP2D) based on patient responses. Participants will be closely monitored for safety and efficacy after receiving HP518, particularly those with specific androgen receptor mutations. The findings will inform future studies and treatment options for mCRPC.

Who should consider this trial

Good fit: Ideal candidates include men aged 18 and older with progressive mCRPC who have specific androgen receptor mutations and have previously undergone endocrine therapy and chemotherapy.

Not a fit: Patients who have not progressed after prior treatments or those with neuroendocrine differentiation characteristics may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment choices.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting advanced prostate cancer have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Male, age ≥18
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:

1. Combination of research or commercially available drugs targeting AR
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.

Where this trial is running

Hefei, Anhui and 26 other locations

• The Second Hospital Of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (RECRUITING)
• The Second Affiliated Hospital Of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)
• The First Affiliated Hospital Of Xiamen Univeristy — Xiamen, Fujian, China (NOT_YET_RECRUITING)
• Lanzhou University Second Hospital — Lanzhou, Gansu, China (RECRUITING)
• The Third Affiliated Hospital of Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
• The Affiliated Hospital Of Guizhou Medical University — Guiyang, Guizhou, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Zhengzhou Central Hospital — Zhengzhou, Henan, China (RECRUITING)
• Tongji Hospital — Wuhan, Hubei, China (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)
• The First Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (RECRUITING)
• Shandong Provincial Hospital — Jinan, Shandong, China (RECRUITING)
• The Affiliated Hospital Of Qingdao University — Qingdao, Shandong, China (RECRUITING)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (RECRUITING)
• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• The First Affiliated Hospital Of Xi'An Jiaotong Univeristy — Xi’an, Shanxi, China (RECRUITING)
• Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (RECRUITING)
• West China Hospital Of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• The Affiliated Hospital Of Southwest Medical University — Luzhou, Sichuan, China (RECRUITING)
• Mianyang Central Hospital — Mianyang, Sichuan, China (RECRUITING)
• The Second Affiliated Hospital Of Kunming Medical University — Kunming, Yunnan, China (RECRUITING)
• The Affiliated Hospital Of School Of Medicine Of Ningbo University — Ningbo, Zhejiang, China (RECRUITING)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Qianrong Xiang

Conditions: Metastatic Castration-resistant Prostate Cancer