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New treatment option for Hepatocellular Carcinoma
Official title Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)
ClinicalTrials.gov ID: NCT06698250
What this study is testing
What is Zanzalintinib?
Zanzalintinib is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as XL-092.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have unresectable hepatocellular carcinoma.
- Patients must be treatment naïve for systemic therapy in the unresectable setting.
- ≥ 18 years and ECOG performance status 0-1
- Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs), unless AE(s) are clinically nonsignificant and/or stable on...
- Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment.
You likely can't join if
- Prior treatment with XL092, or PD-1/PD-L1 or CTLA-4 inhibitors.
- 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...
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study...
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic...
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for...
- Concomitant anticoagulation with oral anticoagulants (e.g., warfarin and direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel)...
See the full eligibility criteria
Who can join
- Patients must have unresectable hepatocellular carcinoma.
- Patients must be treatment naïve for systemic therapy in the unresectable setting.
- ≥ 18 years and ECOG performance status 0-1
- 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).
- Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment.
- 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...
- Note that PI approval can be obtained if institution is unable to release blocks.
- Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
- Sexually active fertile people and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for the following durations after the last dose of...
- Female people of childbearing potential must not be pregnant at screening. Female people are considered to be of childbearing potential unless permanent sterilization or documented postmenopausal status criteria are met.
What rules you out
- Prior treatment with XL092, or PD-1/PD-L1 or CTLA-4 inhibitors.
- 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...
- Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment.
- 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...
- 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: people...
- Concomitant anticoagulation with oral anticoagulants (e.g., warfarin and direct thrombin inhibitors) and platelet inhibitors (e.g., clopidogrel). Note: Allowed anticoagulants are low-dose aspirin for cardioprotection...
- Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: a. Cardiovascular disorders: i. Congestive heart failure New York Heart Association Class...
- Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study...
- Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
- Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. people with lesions invading the hepatic portal vasculature are eligible. Note: people with...
- Other clinically significant disorders that would preclude safe study participation.
- Active infection requiring systemic treatment. Note: Prophylactic antibiotic treatment is allowed.
- Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Known positive test for or suspected infection with SARS-CoV-2 within one month before enrollment. Note: demonstration that the subject has fully recovered from the infection is required to be eligible for enrollment
- Serious non-healing wound/ulcer/bone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.
- Malabsorption syndrome.
- Pharmacologically uncompensated, symptomatic hypothyroidism.
- Moderate to severe hepatic impairment (Child-Pugh B or C).
- Requirement for hemodialysis or peritoneal dialysis.
- History of solid organ or allogeneic stem cell transplant.
- Major surgery within 8 weeks prior to first dose of study treatment. Prior laparoscopic nephrectomy within 4 weeks prior to first dose of study treatment. Minor surgery within 10 days before the first dose of study...
- Corrected QT interval calculated by the Fridericia formula (QTcF) \> 450 ms for males or \> 470 for females within 14 days per electrocardiogram (ECG) before first dose of study treatment. Note: Triplicate ECG...
- History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
- Pregnant or lactating females.
- Inability to swallow tablets.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Any other active malignancy or diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with...
- Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.
- Any active, known or suspected autoimmune disease requiring long term treatment with immunosuppressive medications. Note: people with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin...
- Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized...
- Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic people with FT4 abnormalities can be eligible after Principal Investigator approval.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled...
- Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
- Documented hepatic encephalopathy (HE) within 6 months before first dose of study treatment.
- Clinically meaningful ascites (i.e., ascites requiring paracentesis or escalation in diuretics) within 6 months before first dose of study treatment.
- people who have received any local anticancer therapy including surgery, regional ablative therapies including thermal ablation, radiofrequency ablation (RFA), Microwave Ablation (MWA) transarterial chemoembolization...
- Child Pugh score \> 7.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States; Houston, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.