This study is an open-label Phase 1 trial of MM-111.
Phase 1: Patients with any solid tumor type may be enrolled to evaluate the safety and tolerability of MM-111.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States
Indiana University (IUPUI)
Indianapolis, Indiana, United States
Fox Chase Center
Philadelphia, Pennsylvania, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Maximum Tolerated Dose (MTD) or Maximum Feasible Dose
The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 - 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.
Time frame: 28 days
To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)
Time frame: December 2011
To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity
Time frame: December 2011
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