A Phase 1 and Pharmacologic Study of MM-151 in Patients With Refractory Advanced Solid Tumors
This study is a Phase 1 and pharmacologic open-labeled 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. The study will explore a weekly dosing
schedule, an every other week dosing schedule and an every three week dosing schedule. An
Expansion Cohort will be enrolled following demonstration of safety and adequate MM-151
concentration levels in the dose escalation phase. The expansion cohort will further
characterize safety, pharmacokinetics and explore pharmacodynamic endpoints. It is expected
that approximately 4 study sites will participate.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase II dose based either on the maximum tolerated dose (MTD) or maximum dose of 18 mg/kg in patients with advanced solid malignancies.
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Colorado Denver||Denver, Colorado 80262|
|Horizon Oncology Research, Inc.||Lafayette, Indiana|
|South Texas Accelerated Research Therapeutics, LLC (START)||San Antonio, Texas 78229|