Advanced Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase 1/2 Exploratory Study of the TBL1 Inhibitor, Tegavivint (BC2059), in Patients With Advanced Hepatocellular Carcinoma
This study will be conducted in 2 parts. The first part is a phase 1 single-agent dose escalation,optimization, and expansion study of tegavivint in patients with advanced HCC after failure of at least one line of prior systemic therapy. In the second part of the study, the combination of tegavivint plus pembrolizumab will be assessed with a limited dose escalation followed by a randomized dose optimization.
This study will be conducted in patients with advanced hepatocellular carcinoma (HCC) who have progressed after at least one prior line of systemic therapy. Tegavivint will be administered as a single-agent first in a dose escalation, optimization, and subsequent expansion cohort at the recommended phase 2 dose. Single agent dose escalation will follow a standard 3+3 design to determine the tegavivint maximum tolerated dose (MTD). Upon completion of the dose escalation section, the dose selection optimization will expand two selected dose levels before declaring the recommended phase 2 dose (RP2D) for use in the monotherapy dose expansion. If sufficient clinical benefit is observed, the combination of tegavivint with pembrolizumab in patients with mutations in either CTNNB1 or AXIN1 genes and previously treated with a PD-1/PD-L1 inhibitor will be explored in the second part of the study. This study will begin with a brief dose escalation part. The starting dose will be based on the RP2D determined from the monotherapy dose escalation and optimization. The dose escalation will follow a standard 3+3 design and the dose escalation increments for tegavivint will follow the monotherapy dose escalation schedule to determine the combination MTD. Upon completion of the combination dose escalation, a randomized (1:1) dose selection optimization will be used to determine the combination RP2D. ;
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