Recruiting

Phase 1

MEN2312A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Sponsor:

Stemline Therapeutics, Inc.

Code:

NCT06638307

Conditions

Advanced Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MEN2312

Elacestrant

Study Details

Brief summary:

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

Conditions

Advanced Breast Cancer

Study ID

NCT06638307

Start date

Oct 25, 2024

Status verified date

Aug, 2026

Completion date

Oct 23, 2029

Anticipated

Primary completion date

Oct 24, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MEN2312: Monotherapy

Participants will receive MEN2312.

experimental: MEN2312: Combination Therapy (Elacestrant)

Participants will receive MEN2312 in combination with elacestrant.

Interventions

MEN2312

MEN2312 administered as oral tablets.

Elacestrant

Elacestrant administered as oral tablets.

Primary outcome measure

Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 [ Time Frame: Baseline through Day 28 ]
Recommended Phase 2 Dose (RP2D) of MEN2312 [ Time Frame: Baseline through Month 6 ]

Central Contacts and Locations

Central contacts

Stemline Trials

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

Locations

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72703

Principal Investigator:

Joseph Beck, MD

City of Hope

Recruiting

Duarte, California, United States, 31010

Principal Investigator:

Hope Rugo

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093-0698

Principal Investigator:

Rebecca Shatsky

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Jennifer L Caswell-Jin

UCSF Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Principal Investigator:

Amy Chien

UCLA Hematology Oncology - Parkside

Recruiting

Santa Monica, California, United States, 90404

Principal Investigator:

Aditya Bardia, MD, MPH

Yale Comprehensive Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Principal Investigator:

Patricia LoRusso, DO

Advent Health Orlando

Recruiting

Altamonte Springs, Florida, United States, 32701

Principal Investigator:

Wassim Mchayleh, MD

Sarah Cannon Research Institute at Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Principal Investigator:

Cesar Perez Batista, MD

Florida Cancer Specialists & Research Institute (FCS) - Sarasota

Recruiting

Sarasota, Florida, United States, 34232

Principal Investigator:

Judy Wang, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Hatem Soliman

Winship Cancer Institute, Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Manali Bhave

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

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Oana Danciu

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Nan Chen

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Mark Burkard

The University of Kansas Cancer Center

Recruiting

Fairway, Kansas, United States, 66205

Principal Investigator:

Priyanka Sharma

Sidney Kimmel Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Jessica Tao, MD

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Seth Wander, MD, PhD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Antonio Giordano, MD, PhD

START Midwest - Oncology

Recruiting

Grand Rapids, Michigan, United States, 49546

Principal Investigator:

Manish Sharma, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Karthik Giridhar

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Principal Investigator:

Siu-Long Yao

Perlmutter Cancer Center - Sunset Park

Recruiting

Brooklyn, New York, United States, 11220

Principal Investigator:

Nancy Chan

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Principal Investigator:

Nancy Chan

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Nancy Chan

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Sherry Shen

Providence Cancer Institute Franz Clinic

Recruiting

Portland, Oregon, United States, 97213

Principal Investigator:

David Page

The West Clinic, PC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Principal Investigator:

Gregory Vidal

SCRI Oncology Partners Group

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Erika P Hamilton, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

Heather McArthur

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Jason Mouabbi, MD

START San Antonio, LLC

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Amita Patnaik, MD

University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Virginia Kaklamani, MD

START Mountain

Recruiting

West Valley City, Utah, United States, 84119

Principal Investigator:

William McKean, MD, PhD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Alexander Spira, MD, PhD

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Kari Wisinksi

Froedtert Hospital & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Lubna Chaudhary

More Information

Sponsor

Stemline Therapeutics, Inc.

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

First-In-Human
MEN2312
Advanced Breast Cancer
KAT6

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stemline Therapeutics, Inc. on 2026-08-07.