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New combo drug trial aims to control hard-to-treat prostate cancer

NCT ID NCT07244341

Disease control Sponsor: Daiichi Sankyo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial tests whether adding valemetostat to the standard drug darolutamide is safe and tolerable for men with metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and stopped responding to hormone therapy. About 60 adult men with this condition will receive the combination and be monitored for side effects and signs that the cancer is shrinking or slowing down. The goal is to find a safe dose and gather initial evidence of disease control.

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 60 people

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

Started

Dec 2025

Expected to finish

Nov 2029

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.

Key Inclusion Criteria: The clinical site will screen for the full inclusion criteria per protocol. 1. Adult males ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old). 2. Histologically confirmed adenocarcinoma of the prostate. Cases exhibiting neuroendocrine differentiation are eligible for enrollment, except those with a diagnosis of pure small cell carcinoma, which is excluded. 3. Evidence of disease progression as per the PCWG3 modified RECIST v1.1 criteria. 4. Evidence of metastatic disease as confirmed by radiographic imaging (CT, MRI, or bone scan). 5. Ongoing androgen deprivation at time of enrollment. • For participants currently being treated with luteinizing hormone-releasing hormone agonists or antagonists, therapy must have been initiated at least 4 weeks prior to enrollment and treatment must be continued throughout the trial. 6. Baseline PSA expression level of ≥2 ng/mL, according to a documented testing result. 7. Prior therapy with an Androgen Receptor Pathway Inhibitors (ARPI). 8. ECOG PS of 0 or 1 assessed no more than 28 days prior to enrollment. 9. Is willing and able to provide adequate fresh or archival tumor samples with sufficient quantity and tissue quality. A mandatory newly obtained pretreatment biopsy is required, if not clinically contraindicated and at an acceptable risk as determined by the investigator. If newly obtained tissue samples are not possible to obtain, archival tissue obtained from a lesion not previously irradiated and collected after the most recent prior therapy is acceptable. 10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each trial intervention. The length of time required to continue contraception after the last dose for each trial intervention is 3 months. * Must not freeze or donate sperm starting at screening and throughout the Treatment Period, and for at least 3 months after the final trial intervention administration. Note: Preservation of sperm should be considered before enrollment in this trial. • Adhere to either of the following contraception methods: * True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the participant, OR * Uses a penile/external condom when having penile-vaginal intercourse with an NPOCBP, PLUS partner use of an additional contraceptive method, as a condom may break or leak Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. If the contraception requirements in the local label for any trial interventions are more stringent than those above, the local label requirements are to be followed. Key Exclusion Criteria: The clinical site will screen for the full exclusion criteria per protocol. 1. Prior treatment with any epigenetic agents including but not limited to EZH1, EZH2, EZH1/2, or PRC2 inhibitors. 2. Has a super scan as seen in the baseline bone scan. A super scan is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan, such that the presence of additional metastases in the future could not be evaluated. 3. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. 4. Uncontrolled or significant cardiovascular disease, 5. Prior malignancy, active within the previous 3 years except for locally curable cancers that have been apparently cured or successfully resected, such as basal or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the stomach, or carcinoma in situ of the breast. 6. Has active or uncontrolled HBV infection. 7. Has active or uncontrolled HCV infection. 8. Has active or uncontrolled HIV infection.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

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

Metastatic castration resistant prostate cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 4 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beth Isreal Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cancer & Hematology Center

    RECRUITING

    Grand Rapids, Michigan, 49546-2302, United States

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtoku, 135-8550, Japan

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572-4607, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Newton, Massachusetts, 02467, United States

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

  • Fudan University Shanghai Cancer Center - Xuhui District

    RECRUITING

    Shanghai, 200032, China

  • Kobe City Med Cen Gen Hosp.

    RECRUITING

    Kobe, 650-0047, Japan

  • Mater Misericordiae University Hospital

    RECRUITING

    Dublin, D07 R2WY, Ireland

  • Medical College Of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226-3522, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229-6028, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, 277-8577, Japan

  • Northwell Health Cancer Institute (START NY)

    RECRUITING

    Lake Success, New York, 11042-1118, United States

  • Shanghai General Hospital

    RECRUITING

    Shanghai, 200080, China

  • Sun Yatsen University Cancer Center

    RECRUITING

    Guangzhou, 510060, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, 325000, China

  • Toho University Sakura Medical Center

    RECRUITING

    Sakura-shi, 285-8741, Japan

  • University of California San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037-0698, United States

  • Virginia Cancer Specialists (NEXT Virginia)

    RECRUITING

    Fairfax, Virginia, 22031, United States

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