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

June 9, 2026 updated by: Stemline Therapeutics, Inc.

A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron - Vall d'Hebron Institute of Oncology (VHIO) Medical Oncology Department
        • Principal Investigator:
          • Cristina Saura Manich
      • Madrid, Spain, 28040
        • Recruiting
        • START Madrid - Hospital Universitario Fundacion Jimenez Diaz
        • Principal Investigator:
          • Bernard Doger de Spevill-Uribe
      • Madrid, Spain, 28007
        • Recruiting
        • IOB - Madrid Fundacion Hermanas Hospitalarias (Hospital Beata Maria Ana)
        • Principal Investigator:
          • Javier C Castán
      • Madrid, Spain, 28050
        • Recruiting
        • START Madrid - Centro Integral Oncologico Clara Campal (CIOCC), Hospital HM Sanchinarro
        • Principal Investigator:
          • Irene M Candilejo
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 Octubre Servico de Oncologia Medica
        • Principal Investigator:
          • Manuel Alva Bianchi
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario De Valencia Oncologia Medica
        • Principal Investigator:
          • Juan Miguel Cejalvo Andjuar
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politecnico La Fe Oncologia Medica
        • Principal Investigator:
          • Ana Santaballa Bertran
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group
        • Principal Investigator:
          • Joseph Beck, MD
    • California
      • Duarte, California, United States, 31010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Hope Rugo
      • La Jolla, California, United States, 92093-0698
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Rebecca Shatsky
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Center
        • Principal Investigator:
          • Jennifer L Caswell-Jin
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
        • Principal Investigator:
          • Amy Chien
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA Hematology Oncology - Parkside
        • Principal Investigator:
          • Aditya Bardia, MD, MPH
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Comprehensive Cancer Center
        • Principal Investigator:
          • Patricia LoRusso, DO
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • Advent Health Orlando
        • Principal Investigator:
          • Wassim Mchayleh, MD
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Sarah Cannon Research Institute at Florida Cancer Specialists
        • Principal Investigator:
          • Cesar Perez Batista, MD
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists & Research Institute (FCS) - Sarasota
        • Principal Investigator:
          • Judy Wang, MD
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Hatem Soliman
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory University
        • Principal Investigator:
          • Manali Bhave
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)
        • Principal Investigator:
          • Oana Danciu
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
        • Principal Investigator:
          • Mark Burkard
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center
        • Principal Investigator:
          • Priyanka Sharma
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center
        • Principal Investigator:
          • Jessica Tao, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Principal Investigator:
          • Seth Wander, MD, PhD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Antonio Giordano, MD, PhD
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START Midwest - Oncology
        • Principal Investigator:
          • Manish Sharma, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Karthik Giridhar
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
        • Principal Investigator:
          • Siu-Long Yao
    • New York
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • Perlmutter Cancer Center - Sunset Park
        • Principal Investigator:
          • Nancy Chan
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
        • Principal Investigator:
          • Nancy Chan
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Sherry Shen
      • New York, New York, United States, 10016
        • Recruiting
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • Principal Investigator:
          • Nancy Chan
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute Franz Clinic
        • Principal Investigator:
          • David Page
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners Group
        • Principal Investigator:
          • Erika P Hamilton, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Heather McArthur
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas M.D. Anderson Cancer Center
        • Principal Investigator:
          • Jason Mouabbi, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center San Antonio
        • Principal Investigator:
          • Virginia Kaklamani, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START San Antonio, LLC
        • Principal Investigator:
          • Amita Patnaik, MD
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain
        • Principal Investigator:
          • William McKean, MD, PhD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia
        • Principal Investigator:
          • Alexander Spira, MD, PhD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Principal Investigator:
          • Kari Wisinksi
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital & the Medical College of Wisconsin
        • Principal Investigator:
          • Lubna Chaudhary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
  • Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.
  • Participant must have received at least 1 prior line of endocrine therapy for advanced/metastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants.
  • Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.

Key Exclusion Criteria:

  • Active or newly diagnosed central nervous system metastases.
  • Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement >50%.
  • Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).

Note: Other inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEN2312: Monotherapy
Participants will receive MEN2312.
Drug: MEN2312
MEN2312 administered as oral tablets.
Experimental: MEN2312: Combination Therapy (Elacestrant)
Participants will receive MEN2312 in combination with elacestrant.
Drug: MEN2312
MEN2312 administered as oral tablets.
Drug: Elacestrant
Elacestrant administered as oral tablets.
Other Names:
  • Orserdu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312
Time Frame: Baseline through Day 28
Baseline through Day 28
Recommended Phase 2 Dose (RP2D) of MEN2312
Time Frame: Baseline through Month 6
Baseline through Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR)
Time Frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
Baseline through 28 days after the last treatment administration (up to approximately 7 months)
Clinical Benefit Rate (CBR)
Time Frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
Baseline through 28 days after the last treatment administration (up to approximately 7 months)
Progression-free Survival (PFS)
Time Frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
Baseline through 28 days after the last treatment administration (up to approximately 7 months)
Overall Survival (OS)
Time Frame: Baseline through 3 months after the last treatment administration (up to approximately 9 months)
Baseline through 3 months after the last treatment administration (up to approximately 9 months)
Time to Response (TTR)
Time Frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
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
Time Frame: Up to 6 months post dose
Up to 6 months post dose
AUC of MEN2312 When Administered as Combination Therapy
Time Frame: Up to 6 months post dose
Up to 6 months post dose
Amount of MEN2312 Excreted in Urine When Administered as Monotherapy
Time Frame: Up to 2 months post dose
Up to 2 months post dose
Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy
Time Frame: Up to 6 months post dose
Up to 6 months post dose
Duration of Response (DOR)
Time Frame: Baseline through 28 days after the last treatment administration (up to approximately 7 months)
Baseline through 28 days after the last treatment administration (up to approximately 7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stemline Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEN2312-01
  • 2024-514661-19-00 (Ctis)
  • U1111-1308-5349 (Other Identifier: UTN number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe