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A Phase I/II Open-Label Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer in China
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
Details
| Lead sponsor | Hinova Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 84 |
| Start date | 2023-12-26 |
| Completion | 2026-09 |
Conditions
- Metastatic Castration-resistant Prostate Cancer
Interventions
- HP518 - Dose Escalation
- HP518 - Dose Escalation
- HP518 -Dose Expansion
Primary outcomes
- Incidences of Protocol-defined DLT during the DLT assessment period , characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drugorally administered HP518 (Part 1) — 28 DAYS
To evaluate the safety and tolerability and determine the MTD and the RP2D of orally administered HP518 (Part 1) - Incidence of Treatment-Emergent Adverse Events characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness — Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1) - Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing — Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1) - Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing — Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1) - Incidence of ECG (PR, QRS, QT, and QTcF intervals) abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing — Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1) - PSA50 response rate — 12 weeks
Proportion of patients showing a PSA decline by ≥50% between baseline and Week 12 of dosing with HP518.
Countries
China