Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer (NCT07042919) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer
United States53 participantsStarted 2026-03-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with confirmed diagnosed hepatocellular carcinoma (HCC) who are not amendable to curative treatments
* 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
* 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
* Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* 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
* Patients must be age ≥ 18 years
* Patients must exhibit a/an Eastern Cooperative Oncology Group (ECOG) Status of 0-1 (Karnofsky ≥ 60%)
* CHILD-PUGH CLASS A: Absolute neutrophil count (ANC) ≥ 1,500/mcL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection
* CHILD-PUGH CLASS B: Absolute neutrophil count (ANC) ≥ 1,200/mcL without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection
* CHILD-PUGH CLASS A: Hemoglobin (Hgb) ≥ 9 g/dL without transfusion within 2 weeks of screening laboratory sample collect…