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New pill takes on Hard-to-Treat prostate cancer

NCT ID NCT06155084

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental oral drug called HP518 in 84 men with metastatic castration-resistant prostate cancer that has spread and stopped responding to standard hormone therapy. The trial has two parts: first, finding the safest dose, then checking how well that dose controls the cancer. Researchers will monitor side effects, drug levels in the blood, and tumor markers like PSA.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HP518 (oral drug)
What this could lead to
If it works, this could point toward a new oral treatment option for men with advanced prostate cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is an early phase 1/2 trial with only 84 participants, so it is too soon to know if HP518 is truly effective or safe. Side effects are still being identified, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male, age ≥18 2. Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II) 3. Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics. 4. 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. 5. the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy. 6. Must have recovered from toxicities related to any prior treatments 7. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy. 8. ECOG performance status score of 0 to 1. Exclusion Criteria: 1. Combination of research or commercially available drugs targeting AR 2. 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. 3. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy). 4. Has significant cardiovascular disease.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, China

  • Lanzhou University Second Hospital

    RECRUITING

    Lanzhou, Gansu, China

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, Liaoning, China

  • Mianyang Central Hospital

    RECRUITING

    Mianyang, Sichuan, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, Shandong, China

  • Shanghai Tenth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

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

    RECRUITING

    Chengdu, Sichuan, China

  • The Affiliated Hospital Of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, China

  • The Affiliated Hospital Of Qingdao University

    RECRUITING

    Qingdao, Shandong, China

  • The Affiliated Hospital Of School Of Medicine Of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, China

  • The Affiliated Hospital Of Southwest Medical University

    RECRUITING

    Luzhou, Sichuan, China

  • The First Affiliated Hospital Of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital Of Xi'An Jiaotong Univeristy

    RECRUITING

    Xi’an, Shanxi, China

  • The First Affiliated Hospital Of Xiamen Univeristy

    NOT_YET_RECRUITING

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The Second Affiliated Hospital Of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The Second Affiliated Hospital Of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, China

  • The Second Hospital Of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The Third Affiliated Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Tongji Hospital

    RECRUITING

    Wuhan, Hubei, China

  • West China Hospital Of Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, China

  • Zhengzhou Central Hospital

    RECRUITING

    Zhengzhou, Henan, China

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