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NCT06638307 | RECRUITING | Advanced Breast Cancer

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

Stemline Therapeutics, Inc.

Brief Summary:

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

Condition or disease

Advanced Breast Cancer

Intervention/treatment

MEN2312

Elacestrant

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 240 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer
Actual Study Start Date : 2024-10-25
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • * Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  • * Participant must have received at least one 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 or during adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants. Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required. No other therapeutic options are considered appropriate by the investigator.
  • * Up to 6 prior lines of systemic therapy (including up to 2 prior lines consisting of chemotherapy, cytotoxic antibody drug conjugate, or a combination of both regimens) are allowed in the advanced/metastatic setting.
  • * Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
  • 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%.
    • Note: Other inclusion/exclusion criteria may apply.
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Location Details

NCT06638307

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arkansas

Highlands Oncology Group

Springdale, arkansas, United States, 72703

RECRUITING

United States, California

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093-0698

RECRUITING

United States, California

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94158

RECRUITING

United States, California

UCLA Hematology Oncology - Parkside

Santa Monica, California, United States, 90404

RECRUITING

United States, Connecticut

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States, 06511

RECRUITING

United States, Florida

Advent Health Orlando

Altamonte Springs, florida, United States, 32701

RECRUITING

United States, Florida

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, florida, United States, 32827

RECRUITING

United States, Florida

Florida Cancer Specialists & Research Institute (FCS) - Sarasota

Sarasota, florida, United States, 34232

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, florida, United States, 33612

RECRUITING

United States, Georgia

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Maryland

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, road cancer

START Midwest - Oncology

Grand Rapids, road cancer, United States, 49546

RECRUITING

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

RECRUITING

United States, New Jersey

Astera Cancer Care

East Brunswick, New Jersey, United States, 08816

RECRUITING

United States, New York

Perlmutter Cancer Center - Sunset Park

Brooklyn, New York, United States, 11220

RECRUITING

United States, New York

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States, 11501

RECRUITING

United States, New York

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Oregon

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

RECRUITING

United States, Tennessee

SCRI Oncology Partners Group

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

START San Antonio, LLC

Saint Anthony, Texas, United States, 78229

RECRUITING

United States, Texas

University of Texas Health Science Center San Antonio

Saint Anthony, Texas, United States, 78229

RECRUITING

United States, Utah

START Mountain

West Valley City, Utah, United States, 84119

RECRUITING

United States, Virginia

NEXT Virginia

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Wisconsin

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States, 53792

RECRUITING

Spain,

IOB - Madrid Hospital Sisters Foundation (Beata Maria Ana Hospital)

Madrid, Spain, 28007

RECRUITING

Spain,

START Madrid - Jimenez Diaz Foundation University Hospital

Madrid, Spain, 28040

RECRUITING

Spain,

START Madrid - Clara Campal Integral Oncology Center (CIOCC), Hospital HM Sanchinarro

Madrid, Spain, 28050