Study on Zanzalintinib for Treating Advanced Liver Cancer in Second Line and Beyond

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07042919

Provider View

This clinical trial is testing a new drug called zanzalintinib to see if it is safe and effective for treating advanced liver cancer that has spread. The study aims to find the best dose and understand how well the drug works in stopping cancer growth.

Patient Parameters

Program Overview

This study is exploring the use of a new medication, zanzalintinib, for patients with advanced liver cancer that has spread to other parts of the body. Zanzalintinib is a type of drug known as a tyrosine kinase inhibitor, which works by blocking signals that tell cancer cells to grow. The trial will test the safety, side effects, and best dose of zanzalintinib, as well as how well it works in controlling the cancer.

Description

The main goal of this study is to determine the safety and best dose of zanzalintinib for patients with advanced liver cancer. The study will also look at how long patients live without the cancer getting worse and how many patients respond to the treatment.

Participants will take zanzalintinib by mouth once a day in 28-day cycles. The treatment will continue as long as it is effective and does not cause unacceptable side effects. Throughout the study, participants will have regular check-ups, including heart scans and blood tests, to monitor their health and the drug's effects.

After finishing the treatment, participants will have follow-up visits to check their health and the status of their cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of liver cancer that cannot be cured with surgery or other treatments.
  • Have tried at least one or two previous treatments for advanced liver cancer, but not cabozantinib.
  • Have a specific liver function score (Child-Pugh class A or B7/B8).
  • Have measurable cancer according to standard criteria.
  • Be 18 years or older.
  • Be in good overall health with a performance status of 0 or 1.
  • Meet specific blood and liver function test requirements.
  • Agree to use effective birth control during the study and for a period after the last dose.
  • Be able to understand and sign a consent form and follow study requirements.
  • Be able to swallow pills or take medication through a feeding tube if necessary.

Exclusion Criteria

  • Have previously taken zanzalintinib or certain other cancer drugs recently.
  • Have had more than two previous treatments for advanced liver cancer.
  • Have unresolved side effects from previous treatments.
  • Have another active cancer that requires treatment.
  • Have untreated or unstable brain metastases.
  • Have a history of severe allergic reactions to similar drugs.
  • Be taking certain blood thinners or complementary medicines.
  • Have uncontrolled health conditions, such as heart problems or infections.
  • Have had recent major surgery or not fully recovered from surgery.
  • Be pregnant or breastfeeding.
  • Have psychiatric or social issues that would affect participation in the study.

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