Not currently recruiting at University of California Health

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

Eligibility: for people ages 18 years and up (full criteria)
Location: at UCLA UCSD
Dates: study started October 2024
completion around October 2026
Principal Investigator: by Rebecca Shatsky (ucsd)Aditya Bardia, MD, MPH (ucla)

Rebecca Shatsky

Description

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

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

Advanced Breast Cancer, First-In-Human, MEN2312, KAT6, Breast Neoplasms, Elacestrant, MEN2312: Monotherapy

Open to people ages 18 years and up

Participants with advanced breast cancer that cannot be cured.
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.
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.

New or active brain metastasis.
Severe internal organ spread that could cause immediate life-threatening problems, including large uncontrolled fluid build-up or severe lung or liver involvement.

Note: Other inclusion/exclusion criteria may apply.

UC San Diego Moores Cancer Center not yet accepting patients
La Jolla California 92093-0698 United States
UCLA Jonsson Comprehensive Cancer Center not yet accepting patients
Los Angeles California 90064-2320 United States
START Mountain accepting new patients
West Valley City Utah 84124 United States
South Texas Accelerated Research Therapeutics accepting new patients
San Antonio Texas 78229 United States
University of Texas Health Science Center San Antonio not yet accepting patients
San Antonio Texas 78229 United States

Rebecca Shatsky (ucsd)
Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 28 research publications
Aditya Bardia, MD, MPH (ucla)
Professor, Medicine. Authored (or co-authored) 276 research publications

Status: accepting new patients at some sites,
but this study is not currently recruiting here
Start Date: October 2024
Completion Date: October 2026 (estimated)
Sponsor: Stemline Therapeutics, Inc.
ID: NCT06638307
Phase: Phase 1 Breast Cancer Research Study
Study Type: Interventional
Participants: Expecting 124 study participants
Last Updated: March 18, 2025