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

Launched by STEMLINE THERAPEUTICS, INC. · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called MEN2312 for adults with advanced breast cancer, which means the cancer has spread and cannot be cured. MEN2312 is a type of medication that targets specific proteins in cancer cells to help slow down or stop the disease from getting worse. The trial is currently looking for participants aged 65 to 74 who have already tried at least one other treatment for their advanced cancer. To qualify, participants must have experienced disease progression after using certain previous therapies, including hormone treatments and specific targeted therapies.

If you or a loved one decides to participate, you will be closely monitored throughout the study to see how well the new treatment works and if there are any side effects. It's important to know that this trial cannot accept individuals with certain serious conditions, like new brain tumors or severe issues affecting major organs. Participating in this study could provide access to an innovative treatment option and contribute to important research that may help others with similar conditions in the future.

Gender

ALL

Eligibility 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.