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

Stemline Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Advanced Breast Cancer

Treatments: Drug: Elacestrant; Drug: MEN2312

Study type: Interventional

Funder types: Industry

Identifiers

NCT06638307

MEN2312-01

U1111-1308-5349 (Other Identifier)

2024-514661-19-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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.

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%.

Note: Other inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

MEN2312: Monotherapy

Experimental group

Description:

Participants will receive MEN2312.

Treatment:

Drug: MEN2312

MEN2312: Combination Therapy (Elacestrant)

Experimental group

Description:

Participants will receive MEN2312 in combination with elacestrant.

Treatment:

Drug: MEN2312

Drug: Elacestrant