Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This phase Ib/II trial tests the safety, side effects, and best dose of zanzalintinib and how well it works in treating patients with hepatocellular (liver) cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Zanzalintinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Giving zanzalintinib may be safe, tolerable, and/or effective in treating patients with advanced liver cancer.
Sponsor: Devalingam Mahalingam
You may qualify if…
- ✓ 3.1.1 Patients with confirmed diagnosed HCC who are not amendable to curative treatments.
- ✓ 3.1.2 Patients must have documented objective radiographic progression during or after treatment with any first or second line therapy, or intolerance to any first or second line therapy, which include immunotherapy-based combination, or non-immunotherapy-based treatment, except cabozantinib.
- ✓ 3.1.3 Patients must have a Child-Pugh class A or Child-Pugh class B (B7 or B8) score for cirrhosis mortality. Child-Pugh class B, B9 is excluded. See Appendix A for Child-Pugh Class Scores.
- ✓ 3.1.4 Patients must have measurable disease according to RECIST v1.1. See Section 7 for the evaluation of measurable disease. See Appendix B for RECIST v1.1 criteria.
- ✓ 3.1.5 Patients may have had up to two prior lines therapy (not including cabozantinib) in the advanced metastatic setting. Palliative radiation or locoregional therapies are not considered a line of therapy.
- ✓ 3.1.6 Patients must be age ≥ 18 years.
- ✓ 3.1.7 Patients must exhibit a/an ECOG Status of 0-1 Refer to Appendix C; (Karnofsky ≥ 60%. See Appendix D.)
- ✓ 3.1.8 Patients must have adequate organ and bone marrow function as defined below in Table 2 (Child-Pugh Class A): Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets (PLT) ≥ 75,000/mcL, International Normalized Ratio (INR) ≤ 1.7 x upper limit of normal (ULN), activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN), Total bilirubin ≤ 3.0 mg/dl, Albumin ≥ 2.5 (g/dL), AST (SGOT) ≤ 5 x institutional ULN, ALT (SGPT) ≤ 5 x institutional ULN, ALP ≤ 5.0 x institutional ULN, Creatinine Clearance \> 40 mL/ minute if serum creatinine is elevated above 1.5 X ULN, Urine protein-to-creatinine ratio (UPCR) ≤ 1.5 mg/mg (≤ 169.8 mg/mmol) creatinine.
You may not qualify if…
- ✕ 3.2.1 Patients with prior treatment with zanzalintinib.
- ✕ 3.2.2 Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study Day 1 treatment.
- ✕ 3.2.3 Patients who have received ≥ 3 prior therapies in the advanced setting.
- ✕ 3.2.4 Patients with prior Cabozantinib use.
- ✕ 3.2.5 Patients who have had chemotherapy, cytotoxic, biologic, radiation, or other systemic anticancer (including investigational) therapy within 4 weeks prior to study Day 1 treatment.
- ✕ 3.2.6 Patients who have received palliative radiation therapy for bone metastasis within 14 days or any other radiation therapy within 4 weeks days before first dose of study treatment.
- ✕ 3.2.7 Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment.
- ✕ 3.2.8 Patients who have received any local anticancer therapy including surgery, PEI, RFA, MWA, transarterial chemoembolization (TACE), or trans arterial radioembolization (TARE) within 28 days prior to first dose of study treatment.
Where it's recruiting
Chicago
Source: ClinicalTrials.gov · NCT07042919 · last updated 2026-06-25