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Lysine Acetyltransferase Inhibitor

MEN2312 for Breast Cancer

New Haven, CT
Phase 1
Recruiting
Research Sponsored by Stemline Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Participants with advanced breast cancer that cannot be cured
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called MEN2312 in adults with advanced breast cancer for the first time.

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Who is the study for?
This trial is for adults with advanced breast cancer. Specific details about eligibility criteria are not provided, but typically participants would need to have a certain stage of cancer and meet health requirements set by the study.Check my eligibility
What is being tested?
The trial is testing MEN2312, a new drug that inhibits an enzyme called KAT6 which may play a role in cancer growth. It's being compared or used in conjunction with Elacestrant, another medication for breast cancer.See study design
What are the potential side effects?
Since this is a first-in-human study, specific side effects of MEN2312 are unknown but could include typical reactions to cancer drugs such as nausea, fatigue, and potential blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with hormone therapy for advanced cancer and it has stopped working.
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My breast cancer is advanced and cannot be cured.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have new or worsening brain metastases.
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My cancer has not caused severe problems like uncontrolled fluid build-up or major lung or liver issues.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MEN2312: MonotherapyExperimental Treatment1 Intervention
Participants will receive MEN2312.
Group II: MEN2312: Combination Therapy (Elacestrant)Experimental Treatment2 Interventions
Participants will receive MEN2312 in combination with elacestrant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elacestrant
2019
Completed Phase 3
~560

Find a Location

Closest Location:START Midwest - Oncology· Grand Rapids, MI· 250 miles

Who is running the clinical trial?

Stemline Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
6,383 Total Patients Enrolled
3 Trials studying Breast Cancer
5,098 Patients Enrolled for Breast Cancer
~68 spots leftby Oct 2025