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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514661-19-00 | EU Trial (CTIS) Number | ||
| U1111-1308-5349 | Other Identifier | UTN number |
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This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEN2312: Monotherapy | Experimental | Participants will receive MEN2312. |
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| MEN2312: Combination Therapy (Elacestrant) | Experimental | Participants will receive MEN2312 in combination with elacestrant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEN2312 | Drug | MEN2312 administered as oral tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Baseline through 28 days after the last treatment administration (up to approximately 7 months) | |
| Duration of Response (DOR) | Baseline through 28 days after the last treatment administration (up to approximately 7 months) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stemline Trials | Contact | 1-877-332-7961 | clinicaltrials@menarinistemline.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Recruiting | Springdale | Arkansas | 72703 | United States |
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| Elacestrant | Drug | Elacestrant administered as oral tablets. |
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| 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 |
| 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 |
| City of Hope | Recruiting | Duarte | California | 31010 | United States |
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| UC San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093-0698 | United States |
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| Stanford Cancer Center | Recruiting | Palo Alto | California | 94304 | United States |
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| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting | San Francisco | California | 94158 | United States |
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| UCLA Hematology Oncology - Parkside | Recruiting | Santa Monica | California | 90404 | United States |
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| Yale Comprehensive Cancer Center | Recruiting | New Haven | Connecticut | 06511 | United States |
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| Advent Health Orlando | Recruiting | Altamonte Springs | Florida | 32701 | United States |
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| Sarah Cannon Research Institute at Florida Cancer Specialists | Recruiting | Orlando | Florida | 32827 | United States |
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| Florida Cancer Specialists & Research Institute (FCS) - Sarasota | Recruiting | Sarasota | Florida | 34232 | United States |
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| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Winship Cancer Institute, Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center) | Recruiting | Chicago | Illinois | 60612 | United States |
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| University of Iowa Health Care | Recruiting | Iowa City | Iowa | 52242 | United States |
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| The University of Kansas Cancer Center | Recruiting | Fairway | Kansas | 66205 | United States |
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| Sidney Kimmel Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Massachusetts General Hospital Cancer Center | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| START Midwest - Oncology | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Astera Cancer Care | Recruiting | East Brunswick | New Jersey | 08816 | United States |
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| Perlmutter Cancer Center - Sunset Park | Recruiting | Brooklyn | New York | 11220 | United States |
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| Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Recruiting | Mineola | New York | 11501 | United States |
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| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Providence Cancer Institute Franz Clinic | Recruiting | Portland | Oregon | 97213 | United States |
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| SCRI Oncology Partners Group | Recruiting | Nashville | Tennessee | 37203 | United States |
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| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| The University of Texas M.D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| START San Antonio, LLC | Recruiting | San Antonio | Texas | 78229 | United States |
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| University of Texas Health Science Center San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| START Mountain | Recruiting | West Valley City | Utah | 84119 | United States |
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| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
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| University of Wisconsin Carbone Cancer Center | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Froedtert Hospital & the Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Hospital Universitario Vall d'Hebron - Vall d'Hebron Institute of Oncology (VHIO) Medical Oncology Department | Recruiting | Barcelona | 08035 | Spain |
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| IOB - Madrid Fundacion Hermanas Hospitalarias (Hospital Beata Maria Ana) | Recruiting | Madrid | 28007 | Spain |
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| START Madrid - Hospital Universitario Fundacion Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario 12 Octubre Servico de Oncologia Medica | Recruiting | Madrid | 28041 | Spain |
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| START Madrid - Centro Integral Oncologico Clara Campal (CIOCC), Hospital HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
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| Hospital Clinico Universitario De Valencia Oncologia Medica | Recruiting | Valencia | 46010 | Spain |
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| Hospital Universitario y Politecnico La Fe Oncologia Medica | Recruiting | Valencia | 46026 | Spain |
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| ID | Term |
|---|---|
| C000626176 | elacestrant |
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