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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

178

Participants

Timeline

Start Date

September 13, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

June 30, 2026

Conditions
Advanced Hepatocellular Carcinoma
Interventions
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"

Trial Locations (8)

28204

RECRUITING

Levine Cancer Institute, Charlotte

33136

RECRUITING

Sylvester Comprehensive Cancer Center, Miami

60637

RECRUITING

University of Chicago, Chicago

75390

RECRUITING

UT Southwestern, Dallas

77030

RECRUITING

MD Anderson Cancer Center, Houston

91010

RECRUITING

City of Hope, Duarte

98133

RECRUITING

Fred Hutchinson Cancer Center, Seattle

M5G2M9

RECRUITING

UHN - Princess Margaret Cancer Centre, Toronto

Sponsors
All Listed Sponsors
lead

Iterion Therapeutics

INDUSTRY

NCT05797805 - A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter