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New pill takes on Hard-to-Treat prostate cancer in early human trial

NCT ID NCT06801236

Disease control Sponsor: Acerand Therapeutics (Hong Kong) Limited Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This early-phase study is testing a new daily pill called ACE-232 in 67 men with metastatic castration-resistant prostate cancer that has stopped responding to standard treatments. The main goals are to check the drug's safety, find the right dose, and see early signs of whether it might help control the cancer. Participants will also take two other medicines (dexamethasone and fludrocortisone) alongside ACE-232.

What this could mean

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

Active substance
ACE-232 tablets taken daily with dexamethasone and fludrocortisone
What this could lead to
If this early trial shows promise, it could point toward a new treatment option for advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 study with only 67 participants, focused mainly on safety and dosing. It is too soon to know if ACE-232 will work or be safe enough for wider use.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 88 people

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

Started

May 2025

Expected to finish

Dec 2028

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: * Provide written informed consent * Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy * Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment; * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has a life expectancy of at least 6 months * Adequate organ function and bone marrow function Exclusion Criteria: * Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period; * Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors/inducers, or P-gp inhibitors, known to prolong the QT interval. * Any previous treatment-related toxicities have not recovered. * Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis. * Severe cardiovascular disorders. * Known gastrointestinal (GI) disorder or GI procedure * History of gastric and duodenal perforation. * History of pituitary dysfunction. * Poorly controlled diabetes mellitus. * Active or uncontrolled autoimmune disease * Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis. * Other malignancies requiring treatment within 3 years prior to the first dose of study drug * Known allergy or hypersensitivity to any of the excipients of ACE-232. * Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

MCRPC (metastatic castration-resistant prostate cancer) Prostate cancer (adenocarcinoma)

How to take part

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

  1. The places running it

    8 sites in 2 countries. 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

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Harvard Medical School-Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • M Health Fairview Clinics and Surgery Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Moffitt Cancer Center, Tampa

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of California San Diego, Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Xcancer (Urology Cancer Center)

    WITHDRAWN

    Omaha, Nebraska, 68130, United States

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