> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-first-in-human-study-of-men2312-in-adults-with-advanced-ecce3c33-363a-4306-8ff1-80b47cb0ac54 > Record changed: 2026-10-13 # A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer NCT06638307 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) Lead sponsor Stemline Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) Start date 2024-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) Number of sites 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Title and summary **Summary** This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Short title** A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Official title** A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Dates **Completion date** 2029-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **First posted** 2024-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Registry last updated** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Primary completion date** 2027-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Start date** 2024-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Number of sites** 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Lead sponsor** Stemline Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Identifiers **Registry ID** NCT06638307 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **ClinicalTrials.gov ID** NCT06638307 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Outcomes ### Primary outcomes 1. Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 Timeframe: Baseline through Day 28 2. Recommended Phase 2 Dose (RP2D) of MEN2312 Timeframe: Baseline through Month 6 ### Secondary outcomes 1. Overall Response Rate (ORR) Timeframe: Baseline through 28 days after the last treatment administration (up to approximately 7 months) 2. Duration of Response (DOR) Timeframe: Baseline through 28 days after the last treatment administration (up to approximately 7 months) 3. Clinical Benefit Rate (CBR) Timeframe: Baseline through 28 days after the last treatment administration (up to approximately 7 months) 4. Progression-free Survival (PFS) Timeframe: Baseline through 28 days after the last treatment administration (up to approximately 7 months) 5. Overall Survival (OS) Timeframe: Baseline through 3 months after the last treatment administration (up to approximately 9 months) 6. Time to Response (TTR) Timeframe: Baseline through 28 days after the last treatment administration (up to approximately 7 months) 7. Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy Timeframe: Up to 6 months post dose 8. AUC of MEN2312 When Administered as Combination Therapy Timeframe: Up to 6 months post dose 9. Amount of MEN2312 Excreted in Urine When Administered as Monotherapy Timeframe: Up to 2 months post dose 10. Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy Timeframe: Up to 6 months post dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. - Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue. - Participant must have received at least 1 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 adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants. - Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required. Key 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%. - Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2). Note: Other inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Sites - Highlands Oncology GroupSpringdale, United StatesRecruiting - City of HopeDuarte, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - Stanford Cancer CenterPalo Alto, United StatesRecruiting - UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesRecruiting - UCLA Hematology Oncology - ParksideSanta Monica, United StatesRecruiting - Yale Comprehensive Cancer CenterNew Haven, United StatesRecruiting - Advent Health OrlandoAltamonte Springs, United StatesRecruiting - Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlando, United StatesRecruiting - Florida Cancer Specialists & Research Institute (FCS) - SarasotaSarasota, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - Winship Cancer Institute, Emory UniversityAtlanta, United StatesRecruiting - University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)Chicago, United StatesRecruiting - University of Chicago Medical CenterChicago, United StatesRecruiting - University of Iowa Health CareIowa City, United StatesRecruiting - The University of Kansas Cancer CenterFairway, United StatesRecruiting - Sidney Kimmel Comprehensive Cancer CenterBaltimore, United StatesRecruiting - Massachusetts General Hospital Cancer CenterBoston, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - START Midwest - OncologyGrand Rapids, United StatesRecruiting - Mayo ClinicRochester, United StatesRecruiting - Astera Cancer CareEast Brunswick, United StatesRecruiting - Perlmutter Cancer Center - Sunset ParkBrooklyn, United StatesRecruiting - Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineola, United StatesRecruiting - Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United StatesRecruiting And 20 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## References ### Other registry identifiers (2) - 2024-514661-19-00 - U1111-1308-5349 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06638307) ## Related records ### Drugs (1) - [Elacestrant hydrochloride](https://trialight.com/data/asset/elacestrant-hydrochloride-13959fda-16a0-4471-b7ed-8c2cda471800.md) ### Lead sponsors (1) - [Stemline Therapeutics, Inc.](https://trialight.com/data/company/stemline-therapeutics-inc-8f570bf8-cb5b-4bf5-af31-54e366e41b52.md) ### Conditions (1) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition ### Targets (1) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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