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, if people can tolerate it, how the body handles it, and if it starts to work against cancer.
The study will be carried out at locations in United States, South Korea and Europe. Approximately 255 participants are expected to participate.
If eligible, participants may enter the study in one of the following:
Part A - MEN2312 Only Dose Escalation - MEN2312 as oral tablets at strengths of 1mg and 5mg.
Part B - MEN2312 Only Dose Expansion and Optimisation - Participants will be randomly given one of two different doses. The daily dose will be chosen based on results and decisions by Sponsor in consultation with the Safety Monitoring Committee.
Part C - MEN2312 Combination with Elacestrant Dose Escalation - Participants will be given MEN2312 in combination with elacestrant. The dose will be chosen based on available data and decisions by the Sponsor in consultation with the Safety Monitoring Committee.
Part D - MEN2312 Combination with Elacestrant- Dose Expansion and Optimisation - Participants will be given MEN2312 in combination with elacestrant. In Part D participants will take MEN2312 and elacestrant (400 mg) orally (by mouth) once daily.
Part E - MEN2312 Combination with Capivasertib and Fulvestrant – Dose Escalation During part F participants will take:
• MEN2312 orally once daily for all days of the treatment cycle
• Capivasertib (400mg) orally for 4 days on followed by 3 days off
• Fulvestrant (500 mg) is given on specific days of each cycle by injection
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/0065
Date of REC Opinion
19 Mar 2025
REC opinion
Further Information Unfavourable Opinion