Overview

A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer

Status:
Recruiting
Trial end date:
2024-02-29
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 12 weeks of daily oral dosing with HP518 after selecting the RP2D of HP518 based on assessments of multiple dose escalation in patients with progressive mCRPC.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hinova Pharmaceuticals Aus Pty Ltd
Criteria
Inclusion Criteria:

1. Has histologically confirmed adenocarcinoma of the prostate

2. Had PSA progression within 12 weeks of study treatment.

3. 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.

4. Has disease progression while receiving abiraterone or enzalutamide, or another
second-generation AR inhibitor

5. Must have recovered from toxicities related to any prior treatments

6. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.

7. ECOG performance status score of 0 to 1.

Exclusion Criteria:

1. Has received more than 1 line of chemotherapy for prostate cancer.

2. Use of enzalutamide, or other second-generation AR inhibitors and/or abiraterone as
follows:

- Received either agent within 4 weeks prior to the start of study drug.

- Discontinued agent without evidence of radiographic or PSA progression.

3. Has had any anticancer treatments, including immunotherapy, chemotherapy, or
radiotherapy within 4 weeks prior to the first dose of HP518.

4. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).

5. Has significant cardiovascular disease.

6. 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.