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Official Title

A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer

Phase
Phase 1
Sponsor
Stemline Therapeutics, Inc.
Enrollment
240
Timeline
Oct 2024 → Oct 2026
About This Study

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

Eligibility Criteria

Inclusion Criteria

  • 1Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  • 2Participant 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.
  • 3Up 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.
  • 4Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.

Exclusion Criteria

  • 1Active or newly diagnosed central nervous system metastases.
  • 2Participants 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%.

Locations

38 sites participating in this study

Emory University - Winship Cancer Institute (WCI) - Oncology

Atlanta, Georgia 30458

Recruiting

Manali Bhave

Mayo Clinic Cancer Center

Phoenix, Arizona 85054

Recruiting

Shakeela Bahadur

Highlands Oncology Group

Springdale, Arkansas 72703

Recruiting

Joseph Beck, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →