A Phase I, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer
Study Identifier:
MEN2312-01
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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Study Summary
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
- Participant must have received at least one 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 or during adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants. Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required. No other therapeutic options are considered appropriate by the investigator.
- Up to 6 prior lines of systemic therapy (including up to 2 prior lines consisting of chemotherapy, cytotoxic antibody drug conjugate, or a combination of both regimens) are allowed in the advanced/metastatic setting.
- Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
Exclusion criteria
- Active or newly diagnosed central nervous system metastases.
- Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement >50%.
- Note: Other inclusion/exclusion criteria may apply.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Manish Sharma
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Bernard Doger de Speville
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Irene Moreno
Status
Recruitment on Hold
Condition(s) Treated at Site
Breast Cancers