RecruitingHepatocellular Carcinoma
Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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).
Sponsor: Anwaar Saeed
You may qualify if…
- ✓ 1. Patients must have unresectable hepatocellular carcinoma.
- ✓ 2. Patients must be treatment naïve for systemic therapy in the unresectable setting.
- ✓ 3. ≥ 18 years and ECOG performance status 0-1
- ✓ 4. Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (e.g., physiological replacement of mineralocorticosteroid).
- ✓ 5. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment.
- ✓ 6. Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine. Tumor tissue fresh biopsies are REQUIRED for ALL study participants at screening/baseline unless an archival tumor tissue block is available and fulfills the criteria
- ✓ Note that PI approval can be obtained if institution is unable to release blocks.
- ✓ 7. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
You may not qualify if…
- ✕ 1. Prior treatment with XL092, or PD-1/PD-L1 or CTLA-4 inhibitors.
- ✕ 2. 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.
- ✕ 3. Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
- ✕ 4. 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. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
- ✕ 5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
- ✕ Note: Subjects with an incidental finding of an isolated brain lesion \< 1 cm in diameter may be eligible after Principal Investigator approval if the lesion is radiographically stable for 4 weeks before first dose and does not require treatment per Investigator judgement.
- ✕ Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
- ✕ 6. Concomitant anticoagulation with oral anticoagulants (e.g., warfarin and direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel).
Where it's recruiting
Pennsylvania
Pittsburgh
Texas
Houston · San Antonio
Source: ClinicalTrials.gov · NCT06698250 · last updated 2025-11-06