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

RecruitingPhase 1

Sponsor: Stemline Therapeutics, Inc.

Conditions: Advanced Breast Cancer

Interventions: MEN2312, Elacestrant

Countries: United States, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (45)

Springdale, Arkansas, United States
Duarte, California, United States
La Jolla, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Santa Monica, California, United States
New Haven, Connecticut, United States
Altamonte Springs, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Fairway, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
East Brunswick, New Jersey, United States
Brooklyn, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Portland, Oregon, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
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