This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
185
Progression-free survival (tumor assessments according to RECIST criteria)
Time frame: approximately 24 months
Overall survival
Time frame: approximately 32 months
Time to progression (TTP): Time from randomization to first documented disease progression
Time frame: approximately 24 months
Disease control rate (DCR): Complete response, partial response or stable disease lasting at least 6 weeks
Time frame: approximately 24 months
Safety: Incidence of adverse events
Time frame: approximately 24 months
Pharmacokinetics: Serum concentrations (Cmax,Cmin)
Time frame: Multiple sampling pre- and post-dose Days 1 and 8 Cycle 1, Day 1 Cycle 6, pre-dose Day 1 Cycles 2-11
GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay
Time frame: at screening
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