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Dose escalation using 3+3 design with dose limiting toxicity (DLT) observation period of 28 days.

Additional patients will be enrolled into the recommended dose. These additional patients will undergo all of the same assessments as the patients enrolled in dose escalation with the exception of PK sampling.

Escalating doses to be administered 3 times a week.

GNS561

This is a first in human, open-label dose escalation study to investigate the safety, tolerability and pharmacokinetics of GNS561 in patients Primary and Secondary liver cancer

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 primary and secondary liver cancer. This study will enroll approximately 50 patients and consists of 2 parts: Phase 1(dose escalation) and Phase 2 (expansion). 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, in the Morning and in the evening at the same time everyday, following a meal.

Study of GNS561 in Patients With Liver Cancer

Phase 1/2a Study to Evaluate the Safety, Activity, and Pharmacokinetics of Escalating Doses of GNS561 in Patients With Primary and Secondary Liver Cancer

Dose-Limiting Toxicity will be measured by adverse events by dose level

Genoscience Pharma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of GNS561 in Patients With Liver Cancer	NCT03316222	Hepatocellular ... Cholangiocarcin...	GNS561	18 Years -	Genoscience Pharma
Study of GNS561 in Patients With Liver Cancer	NCT03316222	Hepatocellular ... Cholangiocarcin...	GNS561	18 Years -	Genoscience Pharma
Study of GNS561 in Patients With Liver Cancer	NCT03316222	Hepatocellular ... Cholangiocarcin...	GNS561	18 Years -	Genoscience Pharma

Spots Global Cancer Trial Database for gns561

Every month we try and update this database with for gns561 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gns561

Every month we try and update this database with for gns561 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gns561 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.