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First-in-Human Study of MEN2312 for Advanced Breast Cancer

This study is testing a new drug called MEN2312 for adults with advanced breast cancer. It's the first time MEN2312 is being given to people. You might be able to join if your breast cancer has specific genetic changes (alterations) in PIK3CA, AKT1, or PTEN, and you've already had at least one type of hormone therapy. The study will look at how safe MEN2312 is and what dose works best. It will also compare MEN2312 to another drug called Elacestrant. The study is currently recruiting about 240 participants.

Study design
This is a first-in-human study, meaning it's the first time MEN2312 is being tested in people. It plans to enroll 240 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure dose-limiting toxicity from the start through day 28. The recommended dose will be determined from the start through month 6.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06638307

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Stemline Therapeutics, Inc.
~240 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:MEN2312Elacestrant

At a glance

Recruiting sites
45 of 45 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312
Measured over Baseline through Day 28
+1 more outcome measured

Conditions

Advanced Breast Cancer

Explore related trials

Breast CarcinomaKAT6A GenePIK3CA GenePTEN GeneRAC-Alpha Serine/Threonine Kinase

Where it's being run

45 sites across 21 states
Spain8
California5
Florida4
New York4
Texas4
Illinois2
Massachusetts2
Tennessee2

Who to contact

Stemline Trials
[email protected]
1-877-332-7961
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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).

What this trial measures

  • Number of Participants Experiencing Dose-limiting Toxicity When Administered MEN2312Baseline through Day 28
  • Recommended Phase 2 Dose (RP2D) of MEN2312Baseline through Month 6