Actively Recruiting
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
Led by Stemline Therapeutics, Inc. · Updated on 2026-05-12
240
Participants Needed
36
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
CONDITIONS
Official Title
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 have radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of or during adjuvant endocrine therapy.
- Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment combined 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 of chemotherapy, cytotoxic antibody drug conjugate, or both, are allowed in the advanced/metastatic setting.
- Presence of genetic alterations in PIK3CA, AKT1, or PTEN in tumor tissue.
You will not qualify if you...
- Active or newly diagnosed central nervous system metastases.
- Advanced, symptomatic visceral spread with risk of life-threatening complications, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement greater than 50%.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Highlands Oncology Group
Springdale, Arkansas, United States, 72703
Actively Recruiting
2
City of Hope
Duarte, California, United States, 31010
Actively Recruiting
3
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0698
Actively Recruiting
4
Stanfod Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
5
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
6
UCLA Hematology Oncology - Parkside
Santa Monica, California, United States, 90404
Actively Recruiting
7
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06511
Actively Recruiting
8
Advent Health Orlando
Altamonte Springs, Florida, United States, 32701
Actively Recruiting
9
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
10
Florida Cancer Specialists & Research Institute (FCS) - Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
11
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
12
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)
Chicago, Illinois, United States, 60612
Actively Recruiting
14
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
15
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
16
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
17
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
START Midwest - Oncology
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
19
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
20
Astera Cancer Care
East Brunswick, New Jersey, United States, 08816
Actively Recruiting
21
Perlmutter Cancer Center - Sunset Park
Brooklyn, New York, United States, 11220
Actively Recruiting
22
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
23
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
24
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
25
SCRI Oncology Partners Group
Nashville, Tennessee, United States, 37203
Actively Recruiting
26
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
27
START San Antonio, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
28
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
29
START Mountain
West Valley City, Utah, United States, 84119
Actively Recruiting
30
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
31
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
32
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
33
IOB - Madrid Fundacion Hermanas Hospitalarias (Hospital Beata Maria Ana)
Madrid, Spain, 28007
Actively Recruiting
34
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
35
START Madrid - Centro Integral Oncologico Clara Campal (CIOCC), Hospital HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
36
Hospital Clinico Universitario De Valencia Oncologia Medica
Valencia, Spain, 46010
Actively Recruiting
Research Team
S
Stemline Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here