DKN-01 Inhibition in Advanced Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title: A Phase I/II Multicenter, Open-label Study of DKN-01 to Investigate the Anti-tumor Activity and Safety of DKN-01 in Patients With Hepatocellular Carcinoma and WNT Signaling Alterations

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. Up to 20 patients with advanced HCC will be included in Part A. Tumor assessment will be performed every 8 weeks.The first 10 patients (cohort 1) will start with IV infusion of 300 mg DKN-01 on day 1 and 15 (monotherapy for 28 days). DLTs will be determined. After cycle 2 of monotherapy patients of cohort 1 will continue with combination of 300 mg DKN-01 IV on day 1 and 15 and sorafenib (recommended dose 800 mg per day or at discretion of the investigator) until disease progression. After 2 cycles of combination therapy and prior to the start of the next cohort DLTs will be determined. 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. Depending on the tolerability, the doses may be different for monotherapy and for combination therapy. Up to 50 additional patients with advanced HCC may be enrolled in Part B. Every 8 weeks tumor assessment will be performed. If progression of disease (PD1) is observed with DKN-01 monotherapy, patients will continue on study receiving DKN-01 at the recommend phase II dose for combination therapy. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT03645980
• Study type: Interventional
• Source: Johannes Gutenberg University Mainz
• Contact: Jens U Marquardt, Dr med
• Phone: ++49 451 500
• Email: Jens.Marquardt@uksh.de
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 10, 2018
• Completion date: August 31, 2022