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 - DKN-01 inhibition in advanced liver cancer

niversity Medical Center of the Johannes Gutenberg- University Mainz0 sites70 target enrollmentDecember 13, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: niversity Medical Center of the Johannes Gutenberg- University Mainz
Enrollment: 70
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

December 13, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Medical Center of the Johannes Gutenberg- University Mainz

•Patients meeting all of the following criteria will be considered for enrollment to the trial:
•\-Ambulatory male or female patients \= 18 years
•\-Patients must have histologically confirmed diagnosis
•\-Tumor tissue is mandatory for pre\-treatment evaluation (baseline) (fresh biopsy during
•4\-weeks screening time preferred. Archived specimen is only acceptable, if \= 6 months
•old. Baseline tumor biopsy samples must be available prior to the first dose of DKN\-01\.
•\-Tumor tissue (FFPE) must be received by central histopathology laboratory for correlative studies
•\-Patients with activated WNT/ß\-catenin signaling identified by glutamine synthetase staining (high positive staining in tumor tissue) by an approved lab. Positive staining must be confirmed prior to first dose of DKN\-01\.
•\-Child\-Pugh score \<7 (Child\-Pugh Class A).
•\-Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to resection, locoregional therapy or refractory to locoregional therapy.

•Patients presenting at least one of the following criteria will not be enrolled in the trial:
•\- \-Patients with the following histology of hepatocellular cancer are not eligible for enrollment: fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
•\-New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
•\-Specific cardiac preconditions : Fridericia\-corrected QT interval (QTcF) \>470 msec (female) or \>450 msec (male), or history of congenital long QT syndrome. Any ECG abnormality that in the opinion of the Investigator would preclude safe participation in the study; patients with pacemakers where QTc is not a reliable measure will require an evaluation by a cardiologist to exclude co\-existing cardiac conditions which would prohibit safe participation in the study.
•\-Active, uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry requiring systemic therapy.
•\-human immunodeficiency virus (HIV) positive,
•\-History of major organ transplant (i.e., heart, lungs, liver, or kidney).
•\-History of autologous/allogenic bone marrow transplant.
•\-Serious non\-malignant disease that could compromise protocol objectives in the opinion of the Investigator and/or Sponsor.
•\-Pregnancy or nursing.