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Can a new drug combo tame resistant prostate cancer?

NCT ID NCT07745361

Disease control Sponsor: Monte Rosa Therapeutics, Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This phase 2 trial is testing whether an investigational oral drug called MRT-2359, when combined with the standard prostate cancer drug apalutamide, can lower PSA levels in men with castration-resistant prostate cancer. The study includes about 25 adults with a specific genetic mutation in the androgen receptor. The main goal is to see if the combination reduces PSA, while also checking safety and other signs of anti-tumor activity.

What this could mean

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

Active substance
MRT-2359 (an investigational oral drug) combined with apalutamide (an approved prostate cancer drug)
What this could lead to
If successful, this combination could offer a new treatment option for men with castration-resistant prostate cancer, potentially slowing disease progression and lowering PSA levels.
What could go wrong
This is an early-phase, small trial (25 participants). The combination may not work as hoped, and side effects are possible. Results may not apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 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: * Age \> 18 years * A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 1 * Have histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate without small cell histology and with androgen receptor (AR) mutations * Have not had prior treatment with more than 1 prior taxane-based chemotherapy regimen for castration-resistant prostate cancer * Have no prior treatment with an AR degrader, opevesostat, or similar therapy * Has ongoing (chemical or surgical) androgen deprivation with serum testosterone \< 50 ng/dL (\< 1.7 nM) * Has received prior treatment with poly(ADP-ribose) polymerase (PARP) inhibitor, if appropriate, or deemed ineligible to receive treatment by the Investigator, or has refused PARP inhibitor treatment * Has received prior treatment with at least 1 line of ARPi * Have disease measurable per Prostate Cancer Working Group 4 (PCWG4) criteria, with or without measurable disease by RECIST 1.1 * Be able to provide a tumor biopsy for biomarker analysis during the Screening period * Have adequate organ function Exclusion Criteria: * • Have received prior chemotherapy, definitive radiation, or biological cancer therapy within 21 days before the first dose of study treatment or have any AEs that have failed to recover to baseline * Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE * Have received prior auto-HCT and have not fully recovered from effects of the last transplant * Have received allogeneic hematopoietic stem cell transplantation within past 6 months and/or have symptoms of graft-versus-host disease * Current use of chronic systemic steroid therapy in excess of replacement doses * Have clinically active central nervous system involvement and/or carcinomatous meningitis * Have a confirmed history of (noninfectious) pneumonitis that required steroids * Clinically significant cardiac disease

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Conditions

The condition(s) this trial relates to.

adenocarcinoma castration-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

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

Castration-resistant prostate cancer Castration-resistant prostate cancer (CRPC) 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

    14 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

  • Henry Ford

    NOT_YET_RECRUITING

    Novi, Michigan, 48377, United States

  • Hoag Memorial Hospital Presbyterian

    NOT_YET_RECRUITING

    Newport Beach, California, 92663, United States

  • Kansas University Cancer Center

    NOT_YET_RECRUITING

    Kansas City, Kansas, 66160, United States

  • Lancaster Urology

    NOT_YET_RECRUITING

    Lancaster, Pennsylvania, 17601, United States

  • Levine Cancer Institute

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Rocky Mountain Cancer Center

    NOT_YET_RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Sarah Cannon Research Institute

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37203, United States

  • University of Maryland Greenebaum Cancer Center

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Washington Medical Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98195, United States

  • Virginia Cancer Specialists

    NOT_YET_RECRUITING

    Fairfax, Virginia, 22031, United States

  • XCancer Omaha

    RECRUITING

    Omaha, Nebraska, 68130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.