NCT06638307 A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
| NCT ID | NCT06638307 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Stemline Therapeutics, Inc. |
| Condition | Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-10-25 |
| Primary Completion | 2027-10-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 240 participants in total. It began in 2024-10-25 with a primary completion date of 2027-10-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06638307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06638307 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06638307 currently recruiting?
Yes, NCT06638307 is actively recruiting participants. Contact the research team at clinicaltrials@menarinistemline.com for enrollment information.
Where is the NCT06638307 trial being conducted?
This trial is being conducted at Springdale, United States, Duarte, United States, La Jolla, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06638307 clinical trial?
NCT06638307 is sponsored by Stemline Therapeutics, Inc.. The trial plans to enroll 240 participants.
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