A Phase I Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients - Trial NCT06155084
Access comprehensive clinical trial information for NCT06155084 through Pure Global AI's free database. This Phase 1 trial is sponsored by Hinova Pharmaceuticals Inc. and is currently Not yet recruiting. The study focuses on Metastatic Castration-resistant Prostate Cancer. Target enrollment is 62 participants.
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Study Focus
Sponsor & Location
Hinova Pharmaceuticals Inc.
Timeline & Enrollment
Phase 1
Dec 01, 2023
Sep 01, 2026
Primary Outcome
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),Incidence of Treatment-Emergent Adverse Events characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness,Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing,Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing,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,PSA50 response rate
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
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06155084
Non-Device Trial