University of Texas Southwestern Medical Center
The goal of this clinical trial is to evaluate the combination of zanzalintinib (XL092) and tegavivint in advanced hepatocellular carcinoma (HCC) and Wnt pathway mutations who have progressed after at least one prior line of systemic therapy and are naïve (not previously treated with) standard of care tyrosine kinase inhibitors targeting vascular endothelial growth factor signaling.
This Phase I/II investigator-sponsored trial will evaluate the combination of zanzalintinib (XL092) and tegavivint in participants with advanced hepatocellular carcinoma (HCC) and Wnt pathway mutations (CTNNB1, AXIN1, CREBBP, APC) who have progressed after at least one prior line of systemic therapy and are VEGFR-TKI naïve. The study employs a two-part design beginning with a Phase I dose escalation using a Bayesian Optimal Interval (BOIN) design with cohorts of 3-6 participants per dose level to determine the safety and tolerability of the combination. The dose escalation will evaluate tegavi…
Inclusion Criteria: 1. Male or female, 18 years of age or older 2. Confirmed diagnosis of HCC by either: * Histologically or cytologically documented HCC based on pathology report * Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection 3. Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach 4. C…
40 mg PO once daily
60 mg PO once daily
5 mg/kg IV weekly
6.5 mg/kg IV weekly
Arctuva estimate
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