Metastatic Castration-resistant Prostate CancerPhase 1/2NCT06155084
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
A Phase 1/2 study testing HP518 - Dose Escalation and HP518 -Dose Expansion in people with Metastatic Castration-resistant Prostate Cancer, run by Hinova Pharmaceuticals Inc. at 27 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- HP518 - Dose Escalation and HP518 -Dose Expansion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 27 sitesChina
- Study dates
- 26 Dec 2023to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Guo
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Yinong Niu
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Shusuan Jiang
- Recruiting
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
Chengdu, Sichuan
Jing Liu
- Recruiting
West China Hospital Of Sichuan University
Chengdu, Sichuan
Qiang Dong
Ping Feng
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Hong Luo
- Recruiting
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality
Xian Yu
Qing Jiang
- Recruiting
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
Cundong Liu
- Recruiting
The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou
Qiang Wang
- Recruiting
The Second Hospital Of Anhui Medical University
Hefei, Anhui
Dexin Yu
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Hao Ning
- Recruiting
The Second Affiliated Hospital Of Kunming Medical University
Kunming, Yunnan
Changxing Ke
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu
Li Yang
- Recruiting
The Affiliated Hospital Of Southwest Medical University
Luzhou, Sichuan
Peng Qing
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan
Xiaobo Du
- Recruiting
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Cheng Zhang
- Recruiting
The Affiliated Hospital Of School Of Medicine Of Ningbo University
Ningbo, Zhejiang
Zejun Yan
- Recruiting
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong
Haitao Niu
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Xudong Yao
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
Yu Zeng
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Wei Chen
- Recruiting
Tongji Hospital
Wuhan, Hubei
Zhiquan Hu
- Recruiting
The First Affiliated Hospital Of Xi'An Jiaotong Univeristy
Xi’an, Shanxi
Lei Li
- Not yet recruiting
The First Affiliated Hospital Of Xiamen Univeristy
Xiamen, Fujian
Jinchun Xing
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Jitao Wu
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Tiejun Yang
- Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan
Kai Zhang
About this study
Official title: 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
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
Read the detailed description
This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide preliminary efficacy for the reference of future studies.
- Being tested
- HP518 - Dose Escalation, HP518 -Dose Expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP518 - Dose EscalationDrug
Also called Part 1 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
HP518 - Dose EscalationDrug
Also called Part 1 - Dose Escalation
Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
HP518 -Dose ExpansionDrug
Also called Part 2 - Dose Expansion Oral tablet(s)
Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Dose Escalation, 400mg/d (Cohort1) | Experimental | Oral tablet(s), once daily in 28-day cycles Receives: Drug: HP518 - Dose Escalation |
| Part 1 - Dose Escalation 500mg/d (Cohort 2) | Experimental | Oral tablet(s), once daily in 28-day cycles Receives: Drug: HP518 - Dose Escalation |
| Part 2 - Dose Expansion Oral tablet(s) | Experimental | Oral tablet(s), once daily in 28-day cycles Receives: Drug: HP518 -Dose Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 12 weeks
Secondary outcomes (11)
area under the concentration-time curve (AUC)
Assessment of pharmacokinetic parameters of HP518
Measured: 12 weeks
Maximum concentration (Cmax)
Assessment of pharmacokinetic parameters of HP518
Measured: 12 weeks
Time to maximum concentration (Tmax)
Assessment of pharmacokinetic parameters of HP518
Measured: 12 weeks
Apparent terminal elimination half-life (T1/2)
Assessment of pharmacokinetic parameters of HP518
Measured: 12 weeks
apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Assessment of pharmacokinetic parameters of HP518
Measured: 12 weeks
oral clearance (CL/F)
Assessment of pharmacokinetic parameters of HP518
Measured: 12 weeks
According to PCWG3
evaluate PSA50 response rate: PSA decline by≥50% between baseline and 4 weeks/8 weeks/12 weeks( only Part 1) of dosing with HP518
Measured: 8 weeks
According to PCWG3, evaluate time to PSA progression
PCWG3 definition: PSA increase >25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart) nadir, confirmed by progression at 2 time points at least 3 weeks apart)
Measured: Through study completion, an average of 1 year
Time to radiographic progression by investigator PCWG3 definition
using the RECIST v1.1 and PCWG3 definition
Measured: Through study completion, an average of 1 year
Evaluate the modified best overall response mBOR by investigator
According to RECIST (version 1.1) and PCWG3
Measured: Through study completion, an average of 1 year
analyze the efficacy of patients with different AR phenotypes(Part 2)
According to genetic testing results
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start26 Dec 2023
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinova Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155084
- Sponsor's protocol ID
- HP518-01-01-03
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06155084
- Acronym / sponsor ID
- HP518-01-01-03
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hinova Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide preliminary efficacy for the reference of future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Dose Escalation, 400mg/d (Cohort1) | Experimental | Drug: HP518 - Dose EscalationOral tablet(s), once daily in 28-day cycles |
| Part 1 - Dose Escalation 500mg/d (Cohort 2) | Experimental | Drug: HP518 - Dose EscalationOral tablet(s), once daily in 28-day cycles |
| Part 2 - Dose Expansion Oral tablet(s) | Experimental | Drug: HP518 -Dose ExpansionOral tablet(s), once daily in 28-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HP518 - Dose EscalationAlso: Part 1 - Dose EscalationPart 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort | Drug | Part 1 - Dose Escalation, 400mg/d (Cohort1) |
| HP518 - Dose EscalationAlso: Part 1 - Dose EscalationPart 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort | Drug | Part 1 - Dose Escalation 500mg/d (Cohort 2) |
| HP518 -Dose ExpansionAlso: Part 2 - Dose Expansion Oral tablet(s)Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1. | Drug | Part 2 - Dose Expansion Oral tablet(s) |
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)
Time frame: 28 DAYS
To evaluate the safety and tolerability and determine the MTD and the RP2D of orally 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
Time frame: Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1)
Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Time frame: Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1)
Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Time frame: Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1)
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
Time frame: Through study completion, an average of 1 year
To evaluate the safety of orally administered HP518 (Part 1)
PSA50 response rate
Time frame: 12 weeks
Proportion of patients showing a PSA decline by ≥50% between baseline and Week 12 of dosing with HP518.
11 secondary outcomes
area under the concentration-time curve (AUC)
Time frame: 12 weeks
Maximum concentration (Cmax)
Time frame: 12 weeks
Time to maximum concentration (Tmax)
Time frame: 12 weeks
Apparent terminal elimination half-life (T1/2)
Time frame: 12 weeks
apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: 12 weeks
oral clearance (CL/F)
Time frame: 12 weeks
According to PCWG3
Time frame: 8 weeks
According to PCWG3, evaluate time to PSA progression
Time frame: Through study completion, an average of 1 year
Time to radiographic progression by investigator PCWG3 definition
Time frame: Through study completion, an average of 1 year
Evaluate the modified best overall response mBOR by investigator
Time frame: Through study completion, an average of 1 year
analyze the efficacy of patients with different AR phenotypes(Part 2)
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HP518 - Dose Escalation and HP518 -Dose Expansion in people with Metastatic Castration-resistant Prostate Cancer, run by Hinova Pharmaceuticals Inc. at 27 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qianrong Xiang (+86 28 8505 8465, qrxiang@hinovapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 28 DAYS). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.