drugset / Trial / NCT05797805

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

NCT05797805

Phase 1/2 Recruiting 178 enrolled Iterion Therapeutics
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be conducted in 2 parts. The first part is a phase 1 single-agent dose escalation, and dose optimization, study of tegavivint in patients with advanced HCC after failure of at least one line of prior systemic therapy. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib) followed by a combination dose expansion.

Timeline

Start
2023-09-13
Primary completion
2026-05
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabozantinib Small molecule 40 mg Oral
Subject Cabozantinib Small molecule 60 mg Oral
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Tegavivint Small molecule