Trial Title:
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
NCT ID:
NCT06638307
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
First-In-Human
MEN2312
Advanced Breast Cancer
KAT6
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MEN2312
Description:
MEN2312 administered as oral tablets.
Arm group label:
MEN2312: Combination Therapy (Elacestrant)
Arm group label:
MEN2312: Monotherapy
Intervention type:
Drug
Intervention name:
Elacestrant
Description:
Elacestrant administered as oral tablets.
Arm group label:
MEN2312: Combination Therapy (Elacestrant)
Summary:
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor,
in adult participants with advanced breast cancer.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology Group
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Joseph T Beck, MD
Email:
Principal Investigator
Facility:
Name:
UCLA Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90064-2320
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Aditya Bardia, MD, MPH
Email:
Principal Investigator
Facility:
Name:
Yale Comprehensive Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Patricia LoRusso, DO
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists & Research Institute (FCS) - Villages East
Address:
City:
Lady Lake
Zip:
32159
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Cesar P Batista, MD
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists & Research Institute (FCS) - Sarasota
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Judy Wang, MD
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Seth Wander, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Antonio Giordano, MD, PhD
Email:
Principal Investigator
Facility:
Name:
START Midwest - Oncology
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Manish Sharma, MD
Email:
Principal Investigator
Facility:
Name:
SCRI Oncology Partners Group
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Erika P Hamilton, MD
Email:
Principal Investigator
Facility:
Name:
UT MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Jason Mouabbi, MD
Email:
Principal Investigator
Facility:
Name:
South Texas Accelerated Research Therapeutics
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Amita Patnaik, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas Health Science Center San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Virginia Kaklamani, MD
Email:
Principal Investigator
Facility:
Name:
START Mountain
Address:
City:
West Valley City
Zip:
84124
Country:
United States
Status:
Recruiting
Investigator:
Last name:
William McKean, MD, PhD
Email:
Principal Investigator
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Alexander Spira, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Institut de Cancerologie de l'Ouest
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Mario Campone, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Barbara Pistilli, MD
Email:
Principal Investigator
Facility:
Name:
Universitätsklinikum Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Not yet recruiting
Investigator:
Last name:
Peter Fasching, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Istituto Europeo Di Oncologia S.r.l.
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Giuseppe Curigliano, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Istituto Nazionale dei Tumori, Fondazione IRCCS
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Sara Cresta, MD
Email:
Principal Investigator
Facility:
Name:
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Giampero Rizzo, MD
Email:
Principal Investigator
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Investigator:
Last name:
Joo H Sohn, MD
Email:
Principal Investigator
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
3080
Country:
Korea, Republic of
Status:
Not yet recruiting
Investigator:
Last name:
Kyung-Hun Lee, MD
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Status:
Not yet recruiting
Investigator:
Last name:
Sung Bae Kim, MD
Email:
Principal Investigator
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Status:
Not yet recruiting
Investigator:
Last name:
Seokyun Kang, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz (START)
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Investigator:
Last name:
Bernard Doger de Speville, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario HM Sanchinarro CIOCC (START)
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Not yet recruiting
Investigator:
Last name:
Irene Moreno Candilejo, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Stemline Therapeutics, Inc.
Agency class:
Other
Source:
Stemline Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06638307
