drugset / Trial / NCT03645980

DKN-01 Inhibition in Advanced Liver Cancer

NCT03645980

Non-randomizedSequentialOpen-labelTreatment

Summary

This clinical trial is a prospective, open label, single arm oncological phase I/II trial in patients with hepatocellular carcinoma and WNT signaling alterations. The trial consists of two parts: Part A is a phase I study investigating the safety of DKN-01 administered as mono- as well as combination therapy with sorafenib in a 2 step dose escalation.Part B is a phase II study to investigate the anti-tumor activity and safety of DKN-01 in patients with advanced HCC. DKN-01 is administered at the recommend phase II dose (RP2D) for monotherapy and at the recommend phase II dose for combination therapy established in Part A.

Timeline

Start
2018-10-10
Primary completion
2021-08-31
Completion
2022-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject DKN-01 Monoclonal antibody 150 mg Intravenous
Subject DKN-01 Monoclonal antibody 300 mg Intravenous
Subject DKN-01 Monoclonal antibody 600 mg Intravenous
Background Sorafenib Small molecule