This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of ASG-5ME and identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States
University of California at San Francisco
San Francisco, California, United States
University of Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month after last dose
Best clinical response
Time frame: Every 2 months
Overall and progression-free survival
Time frame: Every month until death or study closure
Concentrations of ASG-5ME and metabolites in blood
Time frame: Through 1 month after last dose
Incidence of antitherapeutic antibodies in blood
Time frame: Through 1 month after last dose
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Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States