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

NCT05252364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-03-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HP518 - Dose Escalation

Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort assignment.

DRUG

HP518 - Dose expansion

Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.

Sponsors & Collaborators

  • Hinova Pharmaceuticals Aus Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Zhonghua Zhou · Hinova Pharmaceuticals USA, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-14
Primary Completion
2024-01-22
Completion
2024-01-22
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05252364 on ClinicalTrials.gov