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

Purpose

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

Condition

  • Advanced Breast Cancer

Eligibility

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

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.

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 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

The University of Kansas Cancer Center
Fairway, Kansas 66205

More Details

Status
Recruiting
Sponsor
Stemline Therapeutics, Inc.

Study Contact

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