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

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: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Participants with advanced breast cancer that cannot be cured.
• Participant must have received at least one prior line of endocrine therapy for advanced/metastatic disease. Progression on previous cyclin-dependent kinase 4/6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.
• Up to 6 prior lines of therapy are allowed. Up to 2 prior chemotherapy and/or cytotoxic antibody-drug conjugates regimens in the advanced/metastatic setting is permitted.

Key Exclusion Criteria:

• New or active brain metastasis.
• Severe internal organ spread that could cause immediate life-threatening problems, including large uncontrolled fluid build-up or severe lung or liver involvement.

Note: Other inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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124 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