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Targeted drug shows promise for Hard-to-Treat prostate cancer

NCT ID NCT05828082

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 1 time

Summary

This study tests a drug called M1774 in 20 men with advanced prostate cancer that has a specific genetic change (SPOP mutation) and has stopped responding to standard treatments. The drug works by blocking certain enzymes that help cancer cells grow. The goal is to see if M1774 can shrink or stabilize the cancer.

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 20 people

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

Started

Oct 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * Presence of SPOP mutations in prostate cancer cells, as indicated by Next Generation Sequencing (NGS) * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) by chest x-ray or as \>= 10 mm (\>= 1 cm) with CT scan, MRI, or calipers by clinical exam * Castrate-range testosterone (=\< 50 ng/dL) after androgen deprivation therapy (ADT) or orchiectomy * Prior treatment with second generation anti-androgen (2GAA) and taxane- or lutetium-based therapy. More than one kind of prior treatment with 2GAA and taxane - or lutetium-based therapies is also acceptable * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of M1774 in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal (ULN) * Creatinine =\< 1.5 × ULN * Creatinine clearance \>= 60 mL/min * Creatinine clearance should be measured if estimated glomerular filtration rate (eGFR) is \> 60 mL/min * Hemoglobin \>= 9.0g/dL * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * The effects of M1774 on the developing human fetus are unknown. For this reason and because ATR inhibitors may be teratogenic (Musson et al., 2022), women of child-bearing potential who are partners of men enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to the study, for the duration of study participation, and 6 months after completion of M1774 administration. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. Men enrolled on this study must agree to use adequate contraception prior to study entry, for the duration of study participation, and 3 months after completion of M1774 administration * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants Exclusion Criteria: * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia * Patients who are receiving any other investigational agents * Patients with uncontrolled intercurrent illness * Patients who cannot discontinue proton pump inhibitors (PPIs). H2 receptor antagonists will not be permitted within 12 hours before dosing of M1774 and until 2 hours after dosing of M1774. Antacids will not be permitted within 2 hours before and 2 hours after administration of M1774 * Patients who cannot discontinue drugs that are strong inhibitors of CYP3A4 or CYP1A2 * Patients who cannot discontinue drugs that are hMATE1 or hMATE2-Ksubstrates * Patients with a baseline QC interval \> 470 msec

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Conditions

The condition(s) this trial relates to.

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.

Castration-resistant prostate carcinoma Metastatic castration-resistant prostate carcinoma Refractory prostate carcinoma Stage IVB prostate cancer ajcc V8

Contacts and locations

Locations

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Hospital East

    Shiloh, Illinois, 62269, United States

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080, United States

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160, United States

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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