Evaluating a new oral medication for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Lanzhou University Second Hospital
  Lanzhou, Gansu, China Recruiting

Study contacts

• Study coordinator: Qianrong Xiang
• Email: qrxiang@hinovapharma.com
• Phone: +86 28 8505 8465

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure

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• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

  This trial tests ETB-DualNK-01, a dual-target CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer to see if it is safe and shows early signs of activity.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.