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Testing MEN2312 in adults 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

Phase 1 Interventional Stemline Therapeutics, Inc. · NCT06638307

This study is testing a new drug called MEN2312 to see if it can help adults with advanced breast cancer that can't be cured, after they have already tried other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorStemline Therapeutics, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations36 sites (Springdale, Arkansas and 35 other locations)
Trial IDNCT06638307 on ClinicalTrials.gov

What this trial studies

This is a first-in-human trial evaluating MEN2312, a KAT6 inhibitor, in adults suffering from advanced breast cancer that cannot be cured. Participants must have previously undergone at least one line of endocrine therapy and have shown progression on specific treatments. The study aims to assess the safety and efficacy of MEN2312 in this patient population. Additionally, Elacestrant will be administered as part of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced breast cancer who have received prior endocrine therapy and have progressed on specific treatments.

Not a fit: Patients with new or active brain metastasis or severe internal organ spread may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer who have limited treatment alternatives.

How similar studies have performed: While this is a first-in-human study, similar approaches targeting KAT6 have shown promise in preclinical models.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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 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.

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%.

Note: Other inclusion/exclusion criteria may apply.

Where this trial is running

Springdale, Arkansas and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Breast CancerFirst-In-HumanMEN2312KAT6
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.