Status:
COMPLETED
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer
Lead Sponsor:
Hinova Pharmaceuticals Aus Pty Ltd
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The overall objective of this Phase 1 study is to evaluate the safety, PK, and anti-tumor activity of 12 weeks of daily oral dosing with HP518 after selecting the RP2D of HP518 based on assessments of...
Detailed Description
This First in Human dose escalation and expansion study of HP518 in patients with mCRPC is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to pr...
Eligibility Criteria
Inclusion
- Has histologically confirmed adenocarcinoma of the prostate.
- Has metastatic disease at study entry documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
- Has disease progression while receiving any ADT, androgen biosynthesis inhibitors, or second-generation AR inhibitors.
- 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
- Has received more than 1 line of chemotherapy for prostate cancer.
- Use of enzalutamide, and/or other second-generation AR inhibitors and/or abiraterone as follows:
- Received any agent within 4 weeks prior to the start of study drug.
- Discontinued agent without evidence of radiographic or PSA progression.
- Has had any anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177Lu-PSMA-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.
- Use of an investigational agent, without evidence of radiographic or PSA progression, within 4 weeks prior to the first dose of HP518 or a period required by local regulation, whichever is longer.
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05252364
Start Date
December 14 2021
End Date
January 22 2024
Last Update
March 21 2024
Active Locations (5)
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1
Border Medical Oncology
Albury, New South Wales, Australia, 2640
2
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
3
Macquarie University
Macquarie Park, New South Wales, Australia, 2113
4
Peter McCallum Cancer Center
Melbourne, Victoria, Australia, 3000