Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer
A Phase Ib/II Study of Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Hepatocellular Carcinoma
Sponsor: Northwestern University + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose-limiting toxicity (DLT) (Phase Ib dose-escalation only)
Time frame: Through the duration of cycle 1 (cycle length = 28 days)
Recommended phase 2 dose (Phase Ib dose escalation only)
Time frame: Up to 1 year
Incidence of adverse events (AEs) (Phase Ib)
Time frame: Up to 30 days from last dose of study treatment
Secondary Endpoints
Incidence of AEs
Median progression-free survival (PFS) (Phase Ib and II)
Overall survival (Phase Ib and II)
Eligibility Criteria
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 …
Read full criteria on CT.gov →✦ Analyst Commentary
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