A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
- Registration Number
- NCT06638307
- Lead Sponsor
- Stemline Therapeutics, Inc.
- Brief Summary
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
- Participants with advanced breast cancer that cannot be cured.
- Participant must have received at least one prior line of endocrine therapy for advanced/metastatic disease. Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.
- Up to 6 prior lines of therapy are allowed. Up to 2 prior chemotherapy and/or cytotoxic antibody-drug conjugates regimens in the advanced/metastatic setting is permitted.
Key
- New or active brain metastasis.
- Severe internal organ spread that could cause immediate life-threatening problems, including large uncontrolled fluid build-up or severe lung or liver involvement.
Note: Other inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description MEN2312: Combination Therapy (Elacestrant) Elacestrant Participants will receive MEN2312 in combination with elacestrant. MEN2312: Combination Therapy (Elacestrant) MEN2312 Participants will receive MEN2312 in combination with elacestrant. MEN2312: Monotherapy MEN2312 Participants will receive MEN2312.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 Baseline through Day 28 Recommended Phase 2 Dose (RP2D) of MEN2312 Baseline through Month 6
- Secondary Outcome Measures
Name Time Method Amount of MEN2312 Excreted in Urine When Administered as Monotherapy Up to 2 months post dose Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy Up to 6 months post dose Overall Response Rate (ORR) Baseline through 28 days after the last treatment administration (up to approximately 7 months) Duration of Objective Response (DOR) Baseline through 28 days after the last treatment administration (up to approximately 7 months) Clinical Benefit Rate (CBR) Baseline through 28 days after the last treatment administration (up to approximately 7 months) Progression-free Survival (PFS) Baseline through 28 days after the last treatment administration (up to approximately 7 months) Overall Survival (OS) Baseline through 3 months after the last treatment administration (up to approximately 9 months) Time to Response (TTR) Baseline through 28 days after the last treatment administration (up to approximately 7 months) Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy Up to 6 months post dose AUC of MEN2312 When Administered as Combination Therapy Up to 6 months post dose
Trial Locations
- Locations (19)
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
UCLA Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Advent Health (Florida Hospital)
🇺🇸Altamonte Springs, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Villages East
🇺🇸Lady Lake, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Sarasota
🇺🇸Sarasota, Florida, United States
Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
START Midwest - Oncology
🇺🇸Grand Rapids, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center (MSKCC)
🇺🇸New York, New York, United States
SCRI Oncology Partners Group
🇺🇸Nashville, Tennessee, United States
UT MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States
START Mountain
🇺🇸West Valley City, Utah, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States