A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Stemline Therapeutics, Inc.
Study ID
NCT06638307
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MEN2312 — DRUG
    MEN2312 administered as oral tablets.
  • Elacestrant — DRUG
    Elacestrant administered as oral tablets.

Study Details

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

Key Dates

Start date
Oct 25, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MEN2312: Monotherapy
    Participants will receive MEN2312.
  • Experimental: MEN2312: Combination Therapy (Elacestrant)
    Participants will receive MEN2312 in combination with elacestrant.

Primary Outcome Measure

Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 [ Time Frame: Baseline through Day 28 ]

Central Contacts

Locations (35)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupSpringdaleArkansas72703
Joseph Beck, MD (PRINCIPAL_INVESTIGATOR)
City of HopeDuarteCalifornia31010
Hope Rugo (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-0698
Rebecca Shatsky (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterPalo AltoCalifornia94304
Jennifer L Caswell-Jin (PRINCIPAL_INVESTIGATOR)
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Amy Chien (PRINCIPAL_INVESTIGATOR)
UCLA Hematology Oncology - ParksideSanta MonicaCalifornia90404
Aditya Bardia, MD, MPH (PRINCIPAL_INVESTIGATOR)
Yale Comprehensive Cancer CenterNew HavenConnecticut06511
Patricia LoRusso, DO (PRINCIPAL_INVESTIGATOR)
Advent Health OrlandoAltamonte SpringsFlorida32701
Wassim Mchayleh, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827
Cesar Perez Batista, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists & Research Institute (FCS) - SarasotaSarasotaFlorida34232
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Hatem Soliman (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Manali Bhave (PRINCIPAL_INVESTIGATOR)
University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)ChicagoIllinois60612
Oana Danciu (PRINCIPAL_INVESTIGATOR)
University of Iowa Health CareIowa CityIowa52242
Mark Burkard (PRINCIPAL_INVESTIGATOR)
The University of Kansas Cancer CenterFairwayKansas66205
Priyanka Sharma (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
Jessica Tao, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Antonio Giordano, MD, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Seth Wander, MD, PhD (PRINCIPAL_INVESTIGATOR)
START Midwest - OncologyGrand RapidsMichigan49546
Manish Sharma, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Karthik Giridhar (PRINCIPAL_INVESTIGATOR)
Astera Cancer CareEast BrunswickNew Jersey08816
Siu-Long Yao (PRINCIPAL_INVESTIGATOR)
Perlmutter Cancer Center - Sunset ParkBrooklynNew York11220
Nancy Chan (PRINCIPAL_INVESTIGATOR)
Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineolaNew York11501
Nancy Chan (PRINCIPAL_INVESTIGATOR)
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Nancy Chan (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Sherry Shen (PRINCIPAL_INVESTIGATOR)
Providence Cancer Institute Franz ClinicPortlandOregon97213
David Page (PRINCIPAL_INVESTIGATOR)
SCRI Oncology Partners GroupNashvilleTennessee37203
Erika P Hamilton, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Heather McArthur (PRINCIPAL_INVESTIGATOR)
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030
Jason Mouabbi, MD (PRINCIPAL_INVESTIGATOR)
START San Antonio, LLCSan AntonioTexas78229
Amita Patnaik, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center San AntonioSan AntonioTexas78229
Virginia Kaklamani, MD (PRINCIPAL_INVESTIGATOR)
START MountainWest Valley CityUtah84119
William McKean, MD, PhD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Kari Wisinksi (PRINCIPAL_INVESTIGATOR)
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Lubna Chaudhary (PRINCIPAL_INVESTIGATOR)

Find similar trials in Springdale, AR

By research site
Highlands Oncology Group· Springdale, ARCity of Hope· Duarte, CAUC San Diego Moores Cancer Center· La Jolla, CAStanford Cancer Center· Palo Alto, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAUCLA Hematology Oncology - Parkside· Santa Monica, CA

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