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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MEN2312: Monotherapy 		Participants will receive MEN2312.
  • Drug: MEN2312
    MEN2312 administered as oral tablets.
Experimental
MEN2312: Combination Therapy (Elacestrant) 		Participants will receive MEN2312 in combination with elacestrant.
  • Drug: MEN2312
    MEN2312 administered as oral tablets.
  • Drug: Elacestrant
    Elacestrant administered as oral tablets.
    Other names:
    • Orserdu

Recruiting Locations

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Stemline Therapeutics, Inc.

Study Contact

Stemline Trials
1-877-332-7961
clinicaltrials@menarinistemline.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.