Last updated on May 2018

Study of GNS561 in Patients With Liver Cancer

Brief description of study

This is a first in human, open-label dose escalation study to investigate the safety, tolerability and pharmacokinetics of GNS561 in patients with advanced malignancies including hepatocellular carcinoma.

Detailed Study Description

This is a multicenter, open-label, uncontrolled, repeat-dose Phase 1/2a study designed to evaluate the safety profile and to determine the recommended Phase 2 dose of GNS561 in patients with advanced malignancies such as HCC. This study will enroll approximately 50 patients and consists of 2 parts: Phase 1(dose escalation) and Phase 2 (continuation). All patients will be treated until the occurrence of an unacceptable toxicity, disease progression, or withdrawal of consent. In this study a treatment cycle is defined as 4 weeks (28 days). Patients are to take their assigned dose of GNS561, at the same time each Monday, Wednesday and Friday following a meal.

Clinical Study Identifier: NCT03316222

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Jules Bordet Institute

Brussel, Belgium
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Recruitment Status: Open

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