This is a Phase I, first-in-human, open label, dose-escalation study of MINT1526A administered alone and in combination with bevacizumab by IV infusion every 3 weeks to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Intravenous escalating dose
Intravenous repeating dose
Unnamed facility
Encinitas, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Aurora, Colorado, United States
Incidence and nature of dose-limiting toxicities (DLTs)
Time frame: Days 1 to 21 of cycle 1
Incidence, nature, and severity of adverse events and serious adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0
Time frame: Day 1 to study completion
Pharmacokinetic parameters of MINT1526A (including total exposure, maximum and minimum serum concentration, clearance, volume of distribution at steady state)
Time frame: Following administration of study drug
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