A Phase 1 Multi-Center Open-Label Dose-Escalation Safety and Pharmacokinetic Clinical Study of Intravenously Administered MM-302 Monotherapy and in Combination with Trastuzumab with or without Cyclophosphamide in Patients with Advanced HER2 Positive Breast Cancer
Kathy Miller, MD
Primary Investigator
Jessica MacLean
Primary Investigator
Overview
This clinical research study is evaluating MM-302, which is an investigational drug, in patients that have breast cancer. The main purpose of this study is to learn about the safety of the drug.
Description
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. Once the maximum tolerated dose is identified, an Expansion Cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. Additional arms will be enrolled to explore the combination of MM-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced HER2 positive breast cancer.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Breast Cancer
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Age: Between 18 Years - 100 Years
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Gender: All
