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

Brief description of study

This is the first study in people to test a new drug called MEN2312 (an experimental cancer drug) for the treatment of advanced breast cancer. MEN2312 works by blocking certain proteins in cancer cells, called KAT6A and KAT6B, that help cancer grow. By blocking these proteins, the drug may help slow down or stop cancer cell growth. This early phase study is designed to learn how safe the drug is, how well people tolerate it, how the drug moves through and affects the body and whether it helps slow or stop tumor growth.

The study will be done in several parts. First is Part A, where patients receive MEN2312 alone. In this part, doctors slowly increase the dose to find a safe dose level. Once a safe dose is found in Part A, patients will be enrolled into other study parts where MEN2312 is combined with other cancer medicines (elacestrant, fulvestrant, or a combination of capivasertib and fulvestrant). These parts are called Parts C, D, E, F, G, and H, and each one is run separately. The safe dose found in Part A will be used to allow dose increases in Parts C, E, and G. After that, Parts D, F, and H will enroll more patients to confirm the best dose and learn more about safety and effectiveness of the drug combinations. Which combination study a patient joins will be decided by the study sponsor, using a central system..

All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-01106
ClinicalTrials.gov Identifier: NCT06638307
Principal Investigator: Nancy Chan.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Barbara E Stelzer, Shridar Ganesan, Elizabeth Comen, Yan Fon Mei, Danielle Seidman, Natalie Jill Klar, Annmarie Johnson-Rowe, Yelena Novik, Marleen I Meyers, Neil Vasan, Elena Katz, Yael Simons, Alexander A Hindenburg, Maryann J Kwa, Akilah Monique Bryant, Nina D'Abreo, Stephanie M Erichsen, Alana Grace Spadalik, Amanda Marie Buzolich, Gregory Edward Totero, Anastasiya Apanasyuk, Ruth Oratz, Stacy Antwi, Naomi Yu Ko, Ariel Karwat, Naamit K. Gerber, Wanqing Iris Zhi, Phyu Phyu Soe, Eliana Ferreira, Douglas K Marks.


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