Recruiting
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
ClinicalTrials.gov IDNCT06638307
PhasePHASE1
Enrollment240
SponsorStemline Therapeutics, Inc.
Age18 Years
SexALL
Conditions studied
Advanced Breast Cancer
About this study
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
Interventions
- Drug: MEN2312 — MEN2312 administered as oral tablets.
- Drug: Elacestrant — Elacestrant administered as oral tablets.
Primary outcomes
- Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 (Baseline through Day 28)
- Recommended Phase 2 Dose (RP2D) of MEN2312 (Baseline through Month 6)
Eligibility information
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 locations
- Highlands Oncology Group, Springdale, Arkansas 72703 United States
- City of Hope, Duarte, California 31010 United States
- UC San Diego Moores Cancer Center, La Jolla, California 92093-0698 United States
- Stanford Cancer Center, Palo Alto, California 94304 United States
- UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94158 United States
- UCLA Hematology Oncology - Parkside, Santa Monica, California 90404 United States
- Yale Comprehensive Cancer Center, New Haven, Connecticut 06511 United States
- Advent Health Orlando, Altamonte Springs, Florida 32701 United States
- Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida 32827 United States
- Florida Cancer Specialists & Research Institute (FCS) - Sarasota, Sarasota, Florida 34232 United States
Showing 10 of 45 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.