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

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

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06638307
Protocol IDs
MEN2312-01 (primary)
NCI-2025-02117
2024-514661-19-00
U1111-1308-5349
Study Sponsor
Stemline Therapeutics, Inc.

Summary

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

Eligibility

  1. Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  2. Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
  3. 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.
  4. Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required. Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.