Status:
RECRUITING
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Lead Sponsor:
Hinova Pharmaceuticals Inc.
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 prog...
Detailed Description
This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of or...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06155084
Start Date
December 26 2023
End Date
September 1 2026
Last Update
December 22 2025
Active Locations (27)
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1
The Second Hospital Of Anhui Medical University
Hefei, Anhui, China
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
3
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
4
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China