This open-label study will demonstrate proof-of-mechanism of HIF1A inhibition by a decrease of HIF1A mRNA after intravenous (IV) infusion of RO7070179 in participants with hepatocellular carcinoma (HCC) who have failed at least one line of systemic therapy. This will be a single arm study and all participants will receive RO7070179, 13 milligram per kilogram per week (mg/kg/week), 2-hour IV infusion on Days 1 and 4 during Week 1 of Cycle 1, followed by once weekly in 6 week cycle. Treatment with RO7070179 will be continued until disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
RO7070179 (13 mg/kg/week) will be administered as 2-hour IV infusion.
Indiana University
Indianapolis, Indiana, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States
NYU Langone Medical Center; Bellevue Hospital
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Change From Baseline to Week 6 in HIF1A mRNA Level in Tumor Tissue
Time frame: Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in hypoxia-inducible factor 1a (HIF1A) Tumor Concentrations
Time frame: Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in HIF2 Tumor Concentrations
Time frame: Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in Vascular Endothelial Growth Factor (VEGF) Tumor Concentrations
Time frame: Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in Erythropoietin (EPO) Tumor Concentrations
Time frame: Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in Prolyl 4 Hydroxylase Tumor Concentrations
Time frame: Pre-dose (baseline) and Week 6
Change From Baseline to Week 6 in CD34/von Willebrand factor (VWF) Tumor Concentrations
Time frame: Pre-dose (baseline) and Week 6
Change in Blood Alpha-fetoprotein (AFP) Concentrations from Baseline
Time frame: Week 1 and Week 4 for Cycle 1 and at Week 1 for subsequent treatment cycles
Time to Progression (TTP) According to Response Evaluation Criteria in Solid Tumors (RECIST) and modified RECIST (mRECIST)
Time frame: Every 12 weeks upto 24 Months
Percentage of Participants With Complete Response (CR) and Partial Response (PR) According to RECIST and mRECIST
Time frame: Every 12 weeks upto 24 Months
Duration of Response (DOR) According to RECIST and mRECIST
Time frame: Every 12 weeks upto 24 Months
Progression Free Survival (PFS) According to RECIST and mRECIST
Time frame: Every 12 weeks upto 24 Months
Overall Survival (OS) According to RECIST and mRECIST
Time frame: Every 12 weeks upto 24 Months
Percentage of Participants With Tumor Growth According to RECIST and mRECIST
Time frame: Every 12 weeks upto 24 Months
Maximum Observed Plasma Concentration (Cmax)
Time frame: pre- and post-dose at Week 1, Week 6
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: pre- and post-dose at Week 1, Week 6
Area under the Concentration-Time Curve From Zero to 168 Hours [AUC (0-168 hours)]
Time frame: pre- and post-dose at Week 1, Week 6
Plasma Decay Half-Life (t1/2)
Time frame: pre- and post-dose at Week 1, Week 6
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