Study on Zanzalintinib (XL-092) with Durvalumab and Tremelimumab for Unresectable Liver Cancer (ZENOBIA)

Sponsor: Anwaar Saeed

Sponsor score: 0

ClinicalTrials ID:NCT06698250

Provider View

This clinical trial is exploring a new treatment combination for patients with liver cancer that cannot be removed by surgery. The study aims to see if the drug XL-092, when used with immunotherapy drugs durvalumab and tremelimumab, can improve treatment outcomes.

Patient Parameters

Program Overview

The purpose of this study is to test if a new drug, Zanzalintinib (XL-092), can work well with immunotherapy drugs to treat liver cancer that cannot be surgically removed. XL-092 is similar to another drug, cabozantinib, and is expected to help the immune system fight cancer. The study will first determine the safest dose to use before moving on to further testing.

Description

This study is testing a new treatment for liver cancer that cannot be removed by surgery. The treatment combines a drug called Zanzalintinib (XL-092) with two immunotherapy drugs, durvalumab and tremelimumab. XL-092 is designed to help the immune system fight cancer by targeting specific proteins that help cancer cells grow. The study will first test the safety of this combination in a small group of patients to find the best dose for future research. Participants will need to provide a tumor sample and meet certain health criteria to join the study. The study will also require participants to use effective birth control during and after the treatment period.

Eligibility Criteria

Inclusion Criteria

  • Have liver cancer that cannot be removed by surgery.
  • Have not received any previous systemic treatment for this type of cancer.
  • Be 18 years or older with good overall health (ECOG performance status 0-1).
  • Have recovered from any previous treatment side effects to a mild level.
  • Have adequate organ and bone marrow function based on lab tests.
  • Provide a tumor sample for testing.
  • Understand and agree to follow the study requirements and sign a consent form.
  • Use effective birth control during the study and for a specified time after treatment.
  • Women must not be pregnant at the start of the study.

Exclusion Criteria

  • Have received previous treatment with XL-092 or similar drugs.
  • Have taken certain cancer treatments within a specified time before the study.
  • Have untreated or unstable brain metastases.
  • Be taking certain blood thinners or have a history of significant bleeding.
  • Have uncontrolled health conditions, such as heart problems or infections.
  • Have had major surgery recently.
  • Be pregnant or breastfeeding.
  • Have other active cancers or serious health conditions that could affect participation.
  • Have a history of autoimmune diseases requiring long-term treatment.

Locations

FACILITYZIPCITYSTATE
UPMC Hillman Cancer Center15232PittsburghPennsylvania

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