A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
NCT ID: NCT06638307
Last Updated: 2026-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
240 participants
INTERVENTIONAL
2024-10-25
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MEN2312: Monotherapy
Participants will receive MEN2312.
MEN2312
MEN2312 administered as oral tablets.
MEN2312: Combination Therapy (Elacestrant)
Participants will receive MEN2312 in combination with elacestrant.
MEN2312
MEN2312 administered as oral tablets.
Elacestrant
Elacestrant administered as oral tablets.
Interventions
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MEN2312
MEN2312 administered as oral tablets.
Elacestrant
Elacestrant administered as oral tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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%.
18 Years
ALL
No
Sponsors
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Stemline Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
UC San Diego Moores Cancer Center
La Jolla, 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
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
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
Countries
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Central Contacts
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Other Identifiers
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2024-514661-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
U1111-1308-5349
Identifier Type: OTHER
Identifier Source: secondary_id
MEN2312-01
Identifier Type: -
Identifier Source: org_study_id
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