drugset / Trial / NCT02564614

A Study of Hypoxia-inducible Factor 1a (HIF1A) Messenger Ribonucleic Acid (mRNA) Antagonist (RO7070179), to Demonstrate Proof-of-mechanism in Adult Participants With Hepatocellular Carcinoma (HCC)

NCT02564614 ↗

Phase 1 Completed 9 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-05-02
Primary completion
2018-01-22
Completion
2018-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject RO7070179 Unknown 6 mg/kg Intravenous
Subject RO7070179 Unknown 10 mg/kg Intravenous
Subject RO7070179 Unknown 13 mg/kg Intravenous