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Advanced Breast CancerPhase 1NCT06638307

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

A Phase 1 study testing MEN2312 and Elacestrant in people with Advanced Breast Cancer, run by Stemline Therapeutics, Inc. at 45 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
What is being tested?
MEN2312 and Elacestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
45 sitesin 2 countries
Study dates
25 Oct 2024to 23 Oct 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

45 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Stemline Trials contact

1-877-332-7961

clinicaltrials@menarinistemline.com

45 sites in 2 countries

United States37 sites, 37 recruiting

  • Advent Health Orlando

    Altamonte Springs, Florida, 32701

    Wassim Mchayleh, MD

    Recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

    Manali Bhave

    Recruiting

  • Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

    Jessica Tao, MD

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Seth Wander, MD, PhD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Antonio Giordano, MD, PhD

    Recruiting

  • Perlmutter Cancer Center - Sunset Park

    Brooklyn, New York, 11220

    Nancy Chan

    Recruiting

  • University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)

    Chicago, Illinois, 60612

    Oana Danciu

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Nan Chen

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Heather McArthur

    Recruiting

  • City of Hope

    Duarte, California, 31010

    Hope Rugo

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Siu-Long Yao

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Alexander Spira, MD, PhD

    Recruiting

  • The University of Kansas Cancer Center

    Fairway, Kansas, 66205

    Priyanka Sharma

    Recruiting

  • The West Clinic, PC dba West Cancer Center

    Germantown, Tennessee, 38138

    Gregory Vidal

    Recruiting

  • START Midwest - Oncology

    Grand Rapids, Michigan, 49546

    Manish Sharma, MD

    Recruiting

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Jason Mouabbi, MD

    Recruiting

  • University of Iowa Health Care

    Iowa City, Iowa, 52242

    Mark Burkard

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093-0698

    Rebecca Shatsky

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Kari Wisinksi

    Recruiting

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Lubna Chaudhary

    Recruiting

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Nancy Chan

    Recruiting

  • SCRI Oncology Partners Group

    Nashville, Tennessee, 37203

    Erika P Hamilton, MD

    Recruiting

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06511

    Patricia LoRusso, DO

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

    Nancy Chan

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Sherry Shen

    Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827

    Cesar Perez Batista, MD

    Recruiting

  • Stanford Cancer Center

    Palo Alto, California, 94304

    Jennifer L Caswell-Jin

    Recruiting

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

    David Page

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Karthik Giridhar

    Recruiting

  • START San Antonio, LLC

    San Antonio, Texas, 78229

    Amita Patnaik, MD

    Recruiting

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

    Virginia Kaklamani, MD

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Amy Chien

    Recruiting

  • UCLA Hematology Oncology - Parkside

    Santa Monica, California, 90404

    Aditya Bardia, MD, MPH

    Recruiting

  • Florida Cancer Specialists & Research Institute (FCS) - Sarasota

    Sarasota, Florida, 34232

    Judy Wang, MD

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72703

    Joseph Beck, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Hatem Soliman

    Recruiting

  • START Mountain

    West Valley City, Utah, 84119

    William McKean, MD, PhD

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Hospital Universitario Vall d'Hebron - Vall d'Hebron Institute of Oncology (VHIO) Medical Oncology Department

    Barcelona, 08035

    Cristina Saura Manich

    Recruiting

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

    Madrid, 28007

    Javier C Castán

    Recruiting

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Bernard Doger de Spevill-Uribe

    Recruiting

  • Hospital Universitario 12 Octubre Servico de Oncologia Medica

    Madrid, 28041

    Manuel Alva Bianchi

    Recruiting

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

    Madrid, 28050

    Irene M Candilejo

    Recruiting

  • Hospital Clinico San Carlos

    Madrid, 484816

    Garcia Saenz

    Recruiting

  • Hospital Clinico Universitario De Valencia Oncologia Medica

    Valencia, 46010

    Juan Miguel Cejalvo Andjuar

    Recruiting

  • Hospital Universitario y Politecnico La Fe Oncologia Medica

    Valencia, 46026

    Ana Santaballa Bertran

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Being tested
MEN2312, Elacestrant
Keywords
First-In-Human, MEN2312, Advanced Breast Cancer, KAT6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEN2312Drug

    MEN2312 administered as oral tablets.

  • ElacestrantDrug

    Also called Orserdu

    Elacestrant administered as oral tablets.

Study groups in NCT06638307
Study groupRoleWhat they receive
MEN2312: MonotherapyExperimentalParticipants will receive MEN2312.
Receives: Drug: MEN2312
MEN2312: Combination Therapy (Elacestrant)ExperimentalParticipants will receive MEN2312 in combination with elacestrant.
Receives: Drug: MEN2312; Drug: Elacestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312

    Measured: Baseline through Day 28

  2. Recommended Phase 2 Dose (RP2D) of MEN2312

    Measured: Baseline through Month 6

Secondary outcomes (10)

  1. Overall Response Rate (ORR)

    Measured: Baseline through 28 days after the last treatment administration (up to approximately 7 months)

  2. Duration of Response (DOR)

    Measured: Baseline through 28 days after the last treatment administration (up to approximately 7 months)

  3. Clinical Benefit Rate (CBR)

    Measured: Baseline through 28 days after the last treatment administration (up to approximately 7 months)

  4. Progression-free Survival (PFS)

    Measured: Baseline through 28 days after the last treatment administration (up to approximately 7 months)

  5. Overall Survival (OS)

    Measured: Baseline through 3 months after the last treatment administration (up to approximately 9 months)

  6. Time to Response (TTR)

    Measured: Baseline through 28 days after the last treatment administration (up to approximately 7 months)

  7. Area Under the Plasma Concentration-time Curve (AUC) of MEN2312 When Administered as Monotherapy

    Measured: Up to 6 months post dose

  8. AUC of MEN2312 When Administered as Combination Therapy

    Measured: Up to 6 months post dose

  9. Amount of MEN2312 Excreted in Urine When Administered as Monotherapy

    Measured: Up to 2 months post dose

  10. Comparison of Plasma Concentration of MEN2312 Monotherapy With MEN2312 Combination Therapy

    Measured: Up to 6 months post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start25 Oct 2024
  3. Primary completion24 Oct 2027 (estimated)
  4. Study completion23 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06638307
Sponsor's protocol ID
MEN2312-01
Other IDs
2024-514661-19-00, U1111-1308-5349
Status last verified
Aug 2026
First submitted
9 Oct 2024
Last updated
7 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEN2312 and Elacestrant in people with Advanced Breast Cancer, run by Stemline Therapeutics, Inc. at 45 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stemline Trials (1-877-332-7961, clinicaltrials@menarinistemline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312 (time frame: Baseline through Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06638307.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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