A Phase I Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

• Status: Recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hinova Pharmaceuticals Inc.

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.