RO7070179
DrugRO7070179 (13 mg/kg/week) will be administered as 2-hour IV infusion.
Other names: SPC2968/EZN-2968
NCT Number: NCT02564614
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Indiana University, Indianapolis, Indiana, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RO7070179 (13 mg/kg/week) will be administered as 2-hour IV infusion.
Other names: SPC2968/EZN-2968
Time frame: Pre-dose (baseline) and Week 6
Time frame: Pre-dose (baseline) and Week 6
Time frame: Pre-dose (baseline) and Week 6
Time frame: Pre-dose (baseline) and Week 6
Time frame: Pre-dose (baseline) and Week 6
Time frame: Pre-dose (baseline) and Week 6
Time frame: Pre-dose (baseline) and Week 6
Time frame: Week 1 and Week 4 for Cycle 1 and at Week 1 for subsequent treatment cycles
Time frame: Every 12 weeks upto 24 Months
Time frame: Every 12 weeks upto 24 Months
Time frame: Every 12 weeks upto 24 Months
Time frame: Every 12 weeks upto 24 Months
Time frame: Every 12 weeks upto 24 Months
Time frame: Every 12 weeks upto 24 Months
Time frame: pre- and post-dose at Week 1, Week 6
Time frame: pre- and post-dose at Week 1, Week 6
Time frame: pre- and post-dose at Week 1, Week 6
Time frame: pre- and post-dose at Week 1, Week 6
Hoffmann-La Roche
Industry
A Phase 1b, Proof of Mechanism, Open-label Study of RO7070179, a Hypoxia-inducible Factor 1a (HIF1A) mRNA Antagonist in Adult Subjects With Hepatocellular Carcinoma (HCC)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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