MEN2312-01
Research type
Research Study
Full title
A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants with Advanced Breast Cancer
IRAS ID
1010771
Contact name
Clinical Development and Clinical Operations
Contact email
Sponsor organisation
Stemline Therapeutics, Inc.
Eudract number
2024-514661-19
Clinicaltrials.gov Identifier
Research summary
We are studying MEN2312 to see if it can help people with advanced breast cancer. We want to find out if it’s safe and if it starts to work against cancer.
The study will be carried out at approximately 70 sites in multiple countries. Approximately 240 participants are expected to participate.
If eligible, participants may enter the study in one of the following:
Part A MEN2312: MEN2312 as oral tablets at strengths of 2 mg, 4 mg, 8 mg, and 12 mg/day.
Part C MEN2312 Combination with Elacestrant: Participants will be given MEN2312 in combination with elacestrant.
Part D MEN2312 Combination with Elacestrant: Participants will be given MEN2312 in combination with elacestrant. The dose of MEN2312 will be chosen based on study data from Part C.
Part E MEN2312 Combination with Capivasertib and Fulvestrant: Participants will be given MEN2312 in combination with capivasertib and fulvestrant. The starting dose of MEN2312 was chosen based on study data from Part A.
Part F MEN2312 Combination with Capivasertib and Fulvestrant: Participants will be given MEN2312 in combination with capivasertib and fulvestrant. The dose of MEN2312 was chosen based on study data from Part E.
Part G MEN2312 Combination with Fulvestrant: Participants will be given MEN2312 in combination with fulvestrant. The starting dose of MEN2312 will be chosen based on study data from Part A.
Part H MEN2312 Combination with Fulvestrant: Participants will be given MEN2312 in combination with fulvestrant. The starting dose of MEN2312 will be chosen based on study data from Part G.
During the study, participants will undergo study related tests and procedures such as (but not limited to) physical examinations, blood and urine samples, electrocardiograms and tumour assessments.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0722
Date of REC Opinion
4 Nov 2025
REC opinion
Further Information Favourable Opinion