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

NCT06638307 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: MEN2312-012024-514661-19-00U1111-1308-5349
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 32

Brief Summary

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

Conditions

Advanced Breast Cancer

Keywords

First-In-Human; MEN2312; Advanced Breast Cancer; KAT6

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• 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)

• 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)

Study Arms (2)

MEN2312: Monotherapy

EXPERIMENTAL

Participants will receive MEN2312.

Drug: MEN2312

MEN2312: Combination Therapy (Elacestrant)

EXPERIMENTAL

Participants will receive MEN2312 in combination with elacestrant.

Drug: MEN2312; Drug: Elacestrant

Interventions

MEN2312 DRUG

MEN2312 administered as oral tablets.

MEN2312: Combination Therapy (Elacestrant); MEN2312: Monotherapy

Elacestrant DRUG

Elacestrant administered as oral tablets.

Also known as: Orserdu

MEN2312: Combination Therapy (Elacestrant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
• Participant must have received at least one 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 or during adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants. Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required. No other therapeutic options are considered appropriate by the investigator.
• Up to 6 prior lines of systemic therapy (including up to 2 prior lines consisting of chemotherapy, cytotoxic antibody drug conjugate, or a combination of both regimens) are allowed in the advanced/metastatic setting.
• Presence of genetic alterations in PIK3CA/AKT1/PTEN in participants' tumor tissue.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Stemline Therapeutics, Inc.: lead

Study Sites (32)

Highlands Oncology Group

Springdale, Arkansas, 72703, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093-0698, United States

RECRUITING

Stanfod Cancer Center

Palo Alto, California, 94304, United States

RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94158, United States

RECRUITING

UCLA Hematology Oncology - Parkside

Santa Monica, California, 90404, United States

RECRUITING

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06511, United States

RECRUITING

Advent Health Orlando

Altamonte Springs, Florida, 32701, United States

RECRUITING

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

RECRUITING

Florida Cancer Specialists & Research Institute (FCS) - Sarasota

Sarasota, Florida, 34232, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

START Midwest - Oncology

Grand Rapids, Michigan, 49546, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

Perlmutter Cancer Center - Sunset Park

Brooklyn, New York, 11220, United States

RECRUITING

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213, United States

RECRUITING

SCRI Oncology Partners Group

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

START San Antonio, LLC

San Antonio, Texas, 78229, United States

RECRUITING

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain

West Valley City, Utah, 84119, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

IOB - Madrid Fundacion Hermanas Hospitalarias (Hospital Beata Maria Ana)

Madrid, 28007, Spain

RECRUITING

START Madrid - Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

START Madrid - Centro Integral Oncologico Clara Campal (CIOCC), Hospital HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

MeSH Terms

Interventions

elacestrant

Central Study Contacts

Stemline Trials

CONTACT

1-877-332-7961; clinicaltrials@menarinistemline.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (29); ES (3)