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

Purpose

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

Condition

  • Advanced Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MEN2312: Monotherapy 		Participants will receive MEN2312.
  • Drug: MEN2312
    MEN2312 administered as oral tablets.
Experimental
MEN2312: Combination Therapy (Elacestrant) 		Participants will receive MEN2312 in combination with elacestrant.
  • Drug: MEN2312
    MEN2312 administered as oral tablets.
  • Drug: Elacestrant
    Elacestrant administered as oral tablets.
    Other names:
    • Orserdu

Recruiting Locations

Highlands Oncology Group
Springdale, Arkansas 72703

City of Hope
Duarte, California 31010

UC San Diego Moores Cancer Center
La Jolla, California 92093-0698

Stanford Cancer Center
Palo Alto, California 94304

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158

UCLA Hematology Oncology - Parkside
Santa Monica, California 90404

Yale Comprehensive Cancer Center
New Haven, Connecticut 06511

Advent Health Orlando
Altamonte Springs, Florida 32701

Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida 32827

Florida Cancer Specialists & Research Institute (FCS) - Sarasota
Sarasota, Florida 34232

Moffitt Cancer Center
Tampa, Florida 33612

Winship Cancer Institute, Emory University
Atlanta, Georgia 30322

University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)
Chicago, Illinois 60612

University of Chicago Medical Center
Chicago, Illinois 60637

University of Iowa Health Care
Iowa City, Iowa 52242

The University of Kansas Cancer Center
Fairway, Kansas 66205

Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

START Midwest - Oncology
Grand Rapids, Michigan 49546

Mayo Clinic
Rochester, Minnesota 55905

Astera Cancer Care
East Brunswick, New Jersey 08816

Perlmutter Cancer Center - Sunset Park
Brooklyn, New York 11220

Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Providence Cancer Institute Franz Clinic
Portland, Oregon 97213

The West Clinic, PC dba West Cancer Center
Germantown, Tennessee 38138

SCRI Oncology Partners Group
Nashville, Tennessee 37203

University of Texas Southwestern Medical Center
Dallas, Texas 75390

The University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030

START San Antonio, LLC
San Antonio, Texas 78229

University of Texas Health Science Center San Antonio
San Antonio, Texas 78229

START Mountain
West Valley City, Utah 84119

NEXT Virginia
Fairfax, Virginia 22031

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792

Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Stemline Therapeutics, Inc.

Study Contact

Stemline Trials
1-877-332-7961
clinicaltrials@menarinistemline.com