NCT05797805

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Iterion Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 and optimization design. 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 design and review of all available safety, efficacy, PK and PD data the Safety Review Committee (SRC) will recommend two dose levels for dose selection optimization. The dose selection optimization will expand the two dose levels to approximately 20 patients randomized (1:1) per dose level (approximately 40 patients total) before declaring the recommended phase 2 dose (RP2D). If sufficient clinical benefit is observed, the combination of tegavivint plus cabozantinib and tegavivint plus lenvatinib will be explored in the second part of the study. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib). The starting dose level of tegavivint will be decided by the SRC and will start at either one dose level below the MTD or at a lower dose as defined by the SRC. The dose escalations will follow a standard 3+3 design, and the dose escalation increments for tegavivint will follow the monotherapy dose escalation schedule to determine the combinations MTDs. Upon completion of the combination dose escalations, approximately 12 additional patients will be enrolled in each combination arm at the tegavivint combination MTDs.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Tegavivint	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
DRUG	Lenvatinib	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 .
DRUG	Cabozantinib	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

Timeline

• Start date: 2023-09-13
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2023-04-04
• Last updated: 2025-07-04

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study