RECRUITING

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

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Conditions

Advanced Breast CancerFirst-In-HumanMEN2312KAT6

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10-25
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06638307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with advanced breast cancer that cannot be cured.
  2. * Participant must have received at least one prior line of endocrine therapy for advanced/metastatic disease. Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.
  3. * Up to 6 prior lines of therapy are allowed. Up to 2 prior chemotherapy and/or cytotoxic antibody-drug conjugates regimens in the advanced/metastatic setting is permitted.
  1. * New or active brain metastasis.
  2. * Severe internal organ spread that could cause immediate life-threatening problems, including large uncontrolled fluid build-up or severe lung or liver involvement.

Contacts and Locations

Study Contact

Stemline Trials
CONTACT
1-877-332-7961
Trials@stemline.com

Study Locations (Sites)

Highlands Oncology Group
Springdale, Arkansas, 72762
United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90064-2320
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06510
United States
Advent Health (Florida Hospital)
Altamonte Springs, Florida, 32701
United States
Florida Cancer Specialists & Research Institute (FCS) - Villages East
Lady Lake, Florida, 32159
United States
Florida Cancer Specialists & Research Institute (FCS) - Sarasota
Sarasota, Florida, 34232
United States
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
START Midwest - Oncology
Grand Rapids, Michigan, 49546
United States
SCRI Oncology Partners Group
Nashville, Tennessee, 37203
United States
UT MD Anderson Cancer Center
Houston, Texas, 77030
United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
United States
START Mountain
West Valley City, Utah, 84124
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Stemline Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-25
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-10-25
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • First-In-Human
  • MEN2312
  • Advanced Breast Cancer
  • KAT6

Additional Relevant MeSH Terms

  • Advanced Breast Cancer