Clinical trial NCT06638307: A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Breast Cancer
Keywords: First-In-Human
MEN2312
Advanced Breast Cancer
KAT6
Lead sponsor: Stemline Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312
timeFrame: Baseline through Day 28
measure: Recommended Phase 2 Dose (RP2D) of MEN2312
timeFrame: Baseline through Month 6
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
measure: Duration of Objective Response (DOR)
timeFrame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
measure: Clinical Benefit Rate (CBR)
timeFrame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
measure: Progression-free Survival (PFS)
timeFrame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
measure: Overall Survival (OS)
timeFrame: Baseline through 3 months after the last treatment administration (up to approximately 9 months)
measure: Time to Response (TTR)
timeFrame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
measure: Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy
timeFrame: Up to 6 months post dose
measure: AUC of MEN2312 When Administered as Combination Therapy
timeFrame: Up to 6 months post dose
measure: Amount of MEN2312 Excreted in Urine When Administered as Monotherapy
timeFrame: Up to 2 months post dose
measure: Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy
timeFrame: Up to 6 months post dose
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center
state: Connecticut
city: Altamonte Springs
country: United States
facility: Advent Health (Florida Hospital)
state: Florida
city: Lady Lake
country: United States
facility: Florida Cancer Specialists & Research Institute (FCS) - Villages East
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists & Research Institute (FCS) - Sarasota
state: Florida
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: START Midwest - Oncology
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center (MSKCC)
state: New York
city: Nashville
country: United States
facility: SCRI Oncology Partners Group
state: Tennessee
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
city: West Valley City
country: United States
facility: START Mountain
state: Utah
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
Study officials:
References: