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

NCT06155084 | Recruiting Phase 1

• 1 other identifier: HP518-01-01-03
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 27

Brief 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

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• 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)

  To evaluate the safety and tolerability and determine the MTD and the RP2D of orally administered HP518 (Part 1)

  28 DAYS

• Incidence of Treatment-Emergent Adverse Events characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness

  To evaluate the safety of orally administered HP518 (Part 1)

  Through study completion, an average of 1 year

• Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

  To evaluate the safety of orally administered HP518 (Part 1)

  Through study completion, an average of 1 year

• Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

  To evaluate the safety of orally administered HP518 (Part 1)

  Through study completion, an average of 1 year

• 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

  To evaluate the safety of orally administered HP518 (Part 1)

  Through study completion, an average of 1 year

• PSA50 response rate

  Proportion of patients showing a PSA decline by ≥50% between baseline and Week 12 of dosing with HP518.

  12 weeks

Secondary Outcomes (11)

• area under the concentration-time curve (AUC)

  12 weeks

• Maximum concentration (Cmax)

  12 weeks

• Time to maximum concentration (Tmax)

  12 weeks

• Apparent terminal elimination half-life (T1/2)

  12 weeks

• apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

  12 weeks

Study Arms (3)

Part 1 - Dose Escalation, 400mg/d (Cohort1)

EXPERIMENTAL

Oral tablet(s), once daily in 28-day cycles

Drug: HP518 - Dose Escalation

Part 1 - Dose Escalation 500mg/d (Cohort 2)

EXPERIMENTAL

Oral tablet(s), once daily in 28-day cycles

Drug: HP518 - Dose Escalation

Part 2 - Dose Expansion Oral tablet(s)

EXPERIMENTAL

Oral tablet(s), once daily in 28-day cycles

Drug: HP518 -Dose Expansion

Interventions

HP518 - Dose Escalation DRUG

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

Also known as: Part 1 - Dose Escalation

Part 1 - Dose Escalation, 400mg/d (Cohort1)

HP518 -Dose Expansion DRUG

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

Also known as: Part 2 - Dose Expansion Oral tablet(s)

Part 2 - Dose Expansion Oral tablet(s)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, age ≥18
• Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II)
• Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics.
• Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT/MRI at the beginning of study.
• the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy.
• Must have recovered from toxicities related to any prior treatments
• Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
• ECOG performance status score of 0 to 1.

You may not qualify if:

• Combination of research or commercially available drugs targeting AR
• Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.
• Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
• Has significant cardiovascular disease.

Sponsors & Collaborators

• Hinova Pharmaceuticals Inc.: lead

Study Sites (27)

The Second Hospital Of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

The First Affiliated Hospital Of Xiamen Univeristy

Xiamen, Fujian, China

NOT YET RECRUITING

Lanzhou University Second Hospital

Lanzhou, Gansu, China

RECRUITING

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

The Affiliated Hospital Of Guizhou Medical University

Guiyang, Guizhou, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Zhengzhou Central Hospital

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, China

RECRUITING

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

The First Affiliated Hospital Of Xi'An Jiaotong Univeristy

Xi’an, Shanxi, China

RECRUITING

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

Chengdu, Sichuan, China

RECRUITING

West China Hospital Of Sichuan University

Chengdu, Sichuan, China

RECRUITING

The Affiliated Hospital Of Southwest Medical University

Luzhou, Sichuan, China

RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, China

RECRUITING

The Second Affiliated Hospital Of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

The Affiliated Hospital Of School Of Medicine Of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Qianrong Xiang

CONTACT

+86 28 8505 8465; qrxiang@hinovapharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: December 26, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (27)