RecruitingPhase 1NCT06638307

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

A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer

Sponsor

Stemline Therapeutics, Inc.

Enrollment

240 participants

Start Date

Oct 25, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Breast Cancer

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is the first human study of MEN2312, a new targeted therapy for people with advanced breast cancer whose tumors have specific genetic changes in the PI3K/AKT/PTEN pathway. It targets patients with hormone receptor-positive breast cancer that has stopped responding to standard hormonal and CDK4/6 inhibitor treatments. **You may be eligible if...** - You are 18 or older with advanced (metastatic or locally recurrent) breast cancer that cannot be cured with surgery - Your tumor has a genetic change in PIK3CA, AKT1, or PTEN - You have already received at least one hormonal therapy for advanced disease AND had progression during or within 12 months of adjuvant endocrine therapy - You have had progression on a CDK4/6 inhibitor combined with hormonal therapy - You have had no more than 6 prior lines of treatment for advanced disease **You may NOT be eligible if...** - You have active or newly diagnosed brain metastases - You have rapidly spreading cancer threatening vital organs in the short term Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMEN2312

MEN2312 administered as oral tablets.

DRUGElacestrant

Elacestrant administered as oral tablets.

Locations(32)

Highlands Oncology Group

Springdale, Arkansas, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Stanfod Cancer Center

Palo Alto, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

UCLA Hematology Oncology - Parkside

Santa Monica, California, United States

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Advent Health Orlando

Altamonte Springs, Florida, United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States

Florida Cancer Specialists & Research Institute (FCS) - Sarasota

Sarasota, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

START Midwest - Oncology

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Perlmutter Cancer Center - Sunset Park

Brooklyn, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

SCRI Oncology Partners Group

Nashville, Tennessee, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

START San Antonio, LLC

San Antonio, Texas, United States

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

START Mountain

West Valley City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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

Madrid, Spain

START Madrid - Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

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

Madrid, Spain

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NCT06638307

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