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OncoMatch/Clinical Trials/NCT06698250

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

Is NCT06698250 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Zanzalintinib and Durvalumab for hepatocellular carcinoma.

Phase 2RecruitingAnwaar SaeedNCT06698250Data as of May 2026

Treatment: Zanzalintinib · Durvalumab · TremelimumabThis 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).

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: XL092 (XL092)

Prior treatment with XL092

Cannot have received: PD-1 inhibitor

Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors

Cannot have received: PD-L1 inhibitor

Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors

Cannot have received: CTLA-4 inhibitor

Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors

Cannot have received: MET inhibitor (cabozantinib)

Receipt of any type of small molecule kinase inhibitor such as cabozantinib or other MET or Dual MET/HGF monoclonal antibodies or MET/HGF tyrosine kinase inhibitors (TKIs), or any other VEGFR TKIs (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.

Cannot have received: VEGFR inhibitor

any other VEGFR TKIs (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment

Cannot have received: cytotoxic chemotherapy

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.

Cannot have received: biologic therapy

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.

Cannot have received: systemic anticancer therapy

Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.

Cannot have received: radiation therapy

Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment.

Cannot have received: radionuclide therapy

Systemic treatment with radionuclides within 6 weeks before first dose of study treatment.

Cannot have received: local anticancer therapy (surgery, thermal ablation, radiofrequency ablation, microwave ablation, transarterial chemoembolization, transarterial radioembolization)

Subjects who have received any local anticancer therapy including surgery, regional ablative therapies including thermal ablation, radiofrequency ablation (RFA), Microwave Ablation (MWA) transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose of study treatment.

Lab requirements

Blood counts

Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment

Liver function

Moderate to severe hepatic impairment (Child-Pugh B or C) excluded; Child Pugh score > 7 excluded

Cardiac function

Congestive heart failure NYHA Class 3 or 4, unstable angina, serious cardiac arrhythmias, uncontrolled hypertension, recent stroke, MI, or other ischemic event within 12 months, prior myocarditis excluded

Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment. Moderate to severe hepatic impairment (Child-Pugh B or C) excluded; Child Pugh score > 7 excluded; see exclusion criteria for cardiac details.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
  • Houston Methodist Neal Cancer Center · Houston, Texas
  • Mays Cancer Center, UT Health San Antonio · San Antonio, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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