NCT06638307

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	MEN2312	MEN2312 administered as oral tablets.
DRUG	Elacestrant	Elacestrant administered as oral tablets.

Timeline

• Start date: 2024-10-25
• Primary completion: 2026-06-01
• Completion: 2026-10-01
• First posted: 2024-10-15
• Last updated: 2026-04-13

Locations

32 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study