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New hope for advanced breast cancer: first human trial of MEN2312 begins

NCT ID NCT06638307

Disease control Sponsor: Stemline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called MEN2312, alone or with another drug (elacestrant), in 240 adults with advanced breast cancer that has specific genetic changes. The main goals are to find a safe dose and check for side effects. It is the first time MEN2312 is being tested in humans.

What this could mean

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

Active substance
MEN2312 (a KAT6 inhibitor) and elacestrant
What this could lead to
If successful, this could point toward a new treatment option for advanced breast cancer with specific genetic changes.
What could go wrong
This is an early Phase 1 trial, so safety and dosing are still being tested. It may not lead to an effective treatment, and side effects are unknown.

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 240 people

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

Started

Oct 2024

Expected to finish

Oct 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

Anyone

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: * Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. * Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue. * Participant must have received at least 1 prior line of endocrine therapy for advanced/metastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants. * Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required. Key Exclusion Criteria: * Active or newly diagnosed central nervous system metastases. * Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%. * Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2). Note: Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma

As listed by the trial registrant

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

Advanced breast cancer

How to take part

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

  1. The places running it

    45 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

  • Advent Health Orlando

    RECRUITING

    Altamonte Springs, Florida, 32701, United States

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • City of Hope

    RECRUITING

    Duarte, California, 31010, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists & Research Institute (FCS) - Sarasota

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Froedtert Hospital & the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Highlands Oncology Group

    RECRUITING

    Springdale, Arkansas, 72703, United States

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 484816, Spain

  • Hospital Clinico Universitario De Valencia Oncologia Medica

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario 12 Octubre Servico de Oncologia Medica

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Vall d'Hebron - Vall d'Hebron Institute of Oncology (VHIO) Medical Oncology Department

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario y Politecnico La Fe Oncologia Medica

    RECRUITING

    Valencia, 46026, Spain

  • IOB - Madrid Fundacion Hermanas Hospitalarias (Hospital Beata Maria Ana)

    RECRUITING

    Madrid, 28007, Spain

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Massachusetts General Hospital Cancer Center

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Perlmutter Cancer Center - Sunset Park

    RECRUITING

    Brooklyn, New York, 11220, United States

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

  • Providence Cancer Institute Franz Clinic

    RECRUITING

    Portland, Oregon, 97213, United States

  • SCRI Oncology Partners Group

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Madrid - Centro Integral Oncologico Clara Campal (CIOCC), Hospital HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • START Midwest - Oncology

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START San Antonio, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

  • Sidney Kimmel Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Stanford Cancer Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • The University of Kansas Cancer Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • The University of Texas M.D. Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The West Clinic, PC dba West Cancer Center

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093-0698, United States

  • UCLA Hematology Oncology - Parkside

    RECRUITING

    Santa Monica, California, 90404, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Texas Health Science Center San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale Comprehensive Cancer Center

    RECRUITING

    New Haven, Connecticut, 06511, United States

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