A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Last updated: May 6, 2025
Sponsor: Stemline Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

MEN2312

Elacestrant

Clinical Study ID

NCT06638307
MEN2312-01
2024-514661-19-00
2024-514661-19
  • Ages > 18
  • All Genders

Study Summary

This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants with advanced breast cancer that cannot be cured.

  • Participant must have received at least one prior line of endocrine therapy foradvanced/metastatic disease. Progression on previous cyclin-dependent kinase 4/6inhibitor treatment in combination with fulvestrant or aromatase inhibitor isrequired.

  • Up to 6 prior lines of therapy are allowed. Up to 2 prior chemotherapy and/orcytotoxic antibody-drug conjugates regimens in the advanced/metastatic setting ispermitted.

Exclusion

Key Exclusion Criteria:

  • New or active brain metastasis.

  • Severe internal organ spread that could cause immediate life-threatening problems,including large uncontrolled fluid build-up or severe lung or liver involvement.

Note: Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: MEN2312
Phase: 1
Study Start date:
October 25, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain, Loire-Atlantique 44805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Institut Claudius Regaud

    Haute-Garonne, 31059
    France

    Site Not Available

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt/Main, Hessen 60590
    Germany

    Site Not Available

  • Kliniken Essen Mitte

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Istituto Nazionale dei Tumori, Fondazione IRCCS

    Milan, 20133
    Italy

    Site Not Available

  • Istituto Europeo Di Oncologia S.r.l.

    Milano, 20141
    Italy

    Site Not Available

  • IRCCS Policlinico San Matteo, Università degli studi di Pavia

    Pavia, 27100
    Italy

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi] 06351
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 5505
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Hospital Beata Maria Ana de Jesus

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz (START)

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro CIOCC (START)

    Madrid, 28050
    Spain

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

    Cambridge, Cambridgeshire Cb2 0Qq
    United Kingdom

    Site Not Available

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California 92093-0698
    United States

    Site Not Available

  • UCLA Jonsson Comprehensive Cancer Center

    Los Angeles, California 90064-2320
    United States

    Site Not Available

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Advent Health (Florida Hospital)

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • Florida Cancer Specialists & Research Institute (FCS) - Villages East

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

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

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • START Midwest - Oncology

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center (MSKCC)

    New York, New York 10065-6800
    United States

    Site Not Available

  • SCRI Oncology Partners Group

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • START Mountain

    West Valley City, Utah 84124
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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