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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Escalating doses of MM-302 as a single agent
Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
University of California San Francisco
San Francisco, California, United States
University of Indiana
Indianapolis, Indiana, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
Karmanos Cancer Center
Detroit, Michigan, United States
The severity and the number of adverse events related to escalating doses of the MM-302.
Time frame: 12 months
The severity and the number of adverse events related to escalating doses of the MM-302 in combination with trastuzumab with or without cyclophosphamide
Time frame: 12 months
Objective response rate of MM-302
Time frame: 12 months
The pharmacokinetics of MM-302 as determined by measuring AUC, Tmax and Cmax
Time frame: 12 months
Immunogenicity of MM-302 by confirming whether MM-302 elicits an immune response or not
Time frame: 12 months
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Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule
Washington University
St Louis, Missouri, United States