New pill takes on Hard-to-Treat prostate cancer
NCT ID NCT06155084
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
27 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Beijing Friendship Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, China
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Chongqing University Cancer Hospital
RECRUITINGChongqing, Chongqing Municipality, China
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, China
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Hunan Cancer Hospital
RECRUITINGChangsha, Hunan, China
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Lanzhou University Second Hospital
RECRUITINGLanzhou, Gansu, China
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Liaoning Cancer Hospital & Institute
RECRUITINGShenyang, Liaoning, China
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Mianyang Central Hospital
RECRUITINGMianyang, Sichuan, China
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Shandong Provincial Hospital
RECRUITINGJinan, Shandong, China
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Shanghai Tenth People's Hospital
RECRUITINGShanghai, Shanghai Municipality, China
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Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
RECRUITINGChengdu, Sichuan, China
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The Affiliated Hospital Of Guizhou Medical University
RECRUITINGGuiyang, Guizhou, China
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The Affiliated Hospital Of Qingdao University
RECRUITINGQingdao, Shandong, China
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The Affiliated Hospital Of School Of Medicine Of Ningbo University
RECRUITINGNingbo, Zhejiang, China
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The Affiliated Hospital Of Southwest Medical University
RECRUITINGLuzhou, Sichuan, China
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The First Affiliated Hospital Of Nanchang University
RECRUITINGNanchang, Jiangxi, China
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The First Affiliated Hospital Of Xi'An Jiaotong Univeristy
RECRUITINGXi’an, Shanxi, China
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The First Affiliated Hospital Of Xiamen Univeristy
NOT_YET_RECRUITINGXiamen, Fujian, China
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The First Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, China
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The Second Affiliated Hospital Of Chongqing Medical University
RECRUITINGChongqing, Chongqing Municipality, China
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The Second Affiliated Hospital Of Kunming Medical University
RECRUITINGKunming, Yunnan, China
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The Second Hospital Of Anhui Medical University
RECRUITINGHefei, Anhui, China
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The Third Affiliated Hospital of Southern Medical University
RECRUITINGGuangzhou, Guangdong, China
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Tongji Hospital
RECRUITINGWuhan, Hubei, China
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West China Hospital Of Sichuan University
RECRUITINGChengdu, Sichuan, China
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Yantai Yuhuangding Hospital
RECRUITINGYantai, Shandong, China
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Zhengzhou Central Hospital
RECRUITINGZhengzhou, Henan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?