Phase 12 Study of Tegavivint Alone and Combined with Cabozantinib or Lenvatinib in Adults with Advanced Hepatocellular Carcinoma After Prior Treatment

What this Trial Is About

Researchers are evaluating tegavivint, an investigational drug, in patients with advanced hepatocellular carcinoma HCC who have not responded to at least one prior systemic therapy. The study is divided into two parts the first focuses on determining the best dose of tegavivint alone, and the second explores combinations of tegavivint with either cabozantinib or lenvatinib. This phase 12 study aims to find safe and effective dosing while monitoring patients closely for side effects and tumor responses. In the first part, tegavivint is given alone once weekly on days 1, 8, 15, and 22 of a 28-day cycle, following a dose escalation plan to find the maximum tolerated dose. After identifying two optimal doses, about 40 patients will be randomized to these doses for further evaluation. If results are promising, the second part begins with dose escalation for combinations of tegavivint plus cabozantinib or tegavivint plus lenvatinib, followed by dose expansions with about 12 patients per combination at the recommended doses. The combination drugs are given daily alongside weekly tegavivint within similar 28-day cycles. Participants will undergo tumor assessments at the start and every 8 weeks during treatment, with safety monitored up to 90 days after the last dose or new cancer therapy. The study includes detailed lab tests, biopsies, and evaluations of organ function before and during treatment. Researchers will track adverse events, dose-limiting toxicities, and tumor responses to understand how well tegavivint works alone and in combination. The total participation duration averages around one year, with ongoing safety and efficacy monitoring throughout this time.

A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma