RecruitingPhase 1Phase 2NCT06155084

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

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

Sponsor

Hinova Pharmaceuticals Inc.

Enrollment

84 participants

Start Date

Dec 26, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new oral drug called HP518 in men with metastatic castration-resistant prostate cancer (mCRPC) — prostate cancer that has spread and continues to grow despite hormone-blocking therapy. HP518 targets a specific mutation in the androgen receptor (the protein that drives prostate cancer growth) and aims to block cancer growth even when standard therapies have failed. **You may be eligible if...** - You are a male aged 18 or older - You have been diagnosed with prostate cancer that has spread (at least 2 bone lesions or soft tissue progression on imaging) - Your cancer has progressed after at least one newer hormonal therapy and at least one line of chemotherapy - You are in good health (ECOG 0–1) and are currently on ongoing hormone-suppression therapy (like LHRH agonist/antagonist or have had both testicles removed) **You may NOT be eligible if...** - You are currently taking other experimental or commercial drugs that also target the androgen receptor - You received cancer treatment (including immunotherapy, chemotherapy, or radiation) within the past 4 weeks - You have a gastrointestinal condition that would prevent proper drug absorption - You have significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHP518 - Dose Escalation

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

DRUGHP518 - Dose Escalation

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

DRUGHP518 -Dose Expansion

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

Locations(27)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital Of Xiamen Univeristy

Xiamen, Fujian, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Affiliated Hospital Of Guizhou Medical University

Guiyang, Guizhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Tongji Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Shandong Provincial Hospital

Jinan, Shandong, China

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital Of Xi'An Jiaotong Univeristy

Xi’an, Shanxi, China

Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital Of Sichuan University

Chengdu, Sichuan, China

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

The Second Affiliated Hospital Of Kunming Medical University

Kunming, Yunnan, China

The Affiliated Hospital Of School Of Medicine Of Ningbo University

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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