A Phase I/IIA Study of GNS561 in Patients with Advanced Liver Cancer

Full Title

Phase 1/2a Study to Evaluate the Safety, Activity and Pharmacokinetics (PK) of Escalating Doses of GNS561 in Patients with Primary Liver Cancer

Purpose

Sorafenib is a drug used to treat liver cancer. In this study, researchers are determining the highest dose of an investigational drug called GNS561 that can be given safely in patients with liver cancer (hepatocellular carcinoma) that persists or continues to grow despite sorafenib.

Recent research has shown that zinc, which can be stored in the liver, helps cells activate proteins that promote cell growth and communication. GNS561 is designed to stop zinc from getting into cancer cells, which can cause them to shrink or die. In laboratory studies, GNS561 blocked cancer cells from growing and traveling to different parts of the body. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic hepatocellular carcinoma that persists or continues to grow despite treatment with sorafenib.
  • At least 4 weeks must pass since the completion of prior treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. James Harding at 646-888-4314.

Protocol

18-242

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators