RecruitingPhase 2NCT06698250

Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)

Phase II Trial of Zanzalintinib (XL-092) in Combination With Durvalumab Plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)


Sponsor

Anwaar Saeed

Enrollment

40 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will investigate if modulating the tumor microenvironment with biologic agents like XL-092 will have synergistic effect when combined with checkpoint based immunotherapeutic treatment of patients with hepatocellular carcinoma (HCC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — zanzalintinib (XL-092), durvalumab, and tremelimumab — as a first-line treatment for liver cancer (hepatocellular carcinoma) that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with inoperable hepatocellular carcinoma (liver cancer) - You have not yet received any systemic (whole-body) treatment for this cancer - You are 18 years or older with a good performance level - Your organs are functioning well enough to safely receive treatment **You may NOT be eligible if...** - You have previously received systemic therapy for liver cancer - You have significant organ dysfunction - You have active autoimmune disease or are on long-term immunosuppressive therapy - You have had prior serious side effects from similar immunotherapy drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanzalintinib

Next generation tyrosine kinase inhibitor (TKI) with the target inhibition profile identical to cabozantinib but with a superior pharmacokinetic profile.

DRUGDurvalumab

Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 (CD279)

DRUGTremelimumab

Tremelimumab is a fully human monoclonal antibody used for the treatment of hepatocellular carcinoma designed to attach to and block CTLA-4, a protein that controls the activity of T cells


Locations(3)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Houston Methodist Neal Cancer Center

Houston, Texas, United States

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06698250


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