RecruitingPhase 1Phase 2NCT05797805

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

A Phase 1/2 Exploratory Study of the TBL1 Inhibitor, Tegavivint (BC2059), in Patients With Advanced Hepatocellular Carcinoma

Sponsor

Iterion Therapeutics

Enrollment

178 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Hepatocellular Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called tegavivint (BC2059) in patients with advanced liver cancer (hepatocellular carcinoma, or HCC) whose cancer has not responded to or is not eligible for other treatments. **You may be eligible if...** - You are 18 or older - You have confirmed HCC (either by tissue biopsy or by standard imaging criteria) - Your cancer is at an advanced stage (Barcelona Clinic stage B or C) and is not suitable for or did not respond to local treatments - Your liver function is relatively preserved (Child-Pugh class A, or class B with a score of 7 or less and no confusion/encephalopathy) **You may NOT be eligible if...** - Your liver function is significantly impaired - You have received certain prior treatments - You have other serious health conditions that your doctor will review Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTegavivint

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. Tegavivint single agent dosing regimen: Tegavivint will be administered weekly on Days 1, 8, 15, and 22 of a 28-day cycle

DRUGLenvatinib

In the second part of the study, the combination of tegavivint plus lenvatinib will be assessed with a limited dose escalation followed by a randomized dose optimization. Tegavivint plus lenvatinib combination dosing regimen: Tegavivint will be administered weekly on Days 1, 8, and 15 and 22 of a 28-day cycle; lenvatinib 8 mg (patients \< 60 kg) or 12 mg (patients ≥ 60 kg) will be administered once daily on days 1-28 of a 28-day cycle .

DRUGCabozantinib

In the second part of the study, the combination of tegavivint plus cabozantinib will be assessed with a limited dose escalation followed by a randomized dose optimization. Tegavivint plus cabozantinib combination dosing regimen: Tegavivint will be administered weekly on Days 1, 8, and 15 and 22 of a 28-day cycle; cabozantinib 60 mg (patients with Child-Pugh A) or 40 mg (patients with Child-Pugh B) will be administered orally once daily on days 1 through 28 of each 28-day cycle