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A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

NCT06155084 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-12-22

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 daily oral dosing with HP518,selecting the RP2D of HP518 based on assessments of patients with progressive mCRPC in dose-escalation phase

Conditions

Interventions

DRUG

HP518 - Dose Escalation

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

DRUG

HP518 - Dose Escalation

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

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 Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-26
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • China

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 NCT06155084 on ClinicalTrials.gov