178
Participants
Start Date
September 13, 2023
Primary Completion Date
May 31, 2026
Study Completion Date
June 30, 2026
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"
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 ."
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"
RECRUITING
Levine Cancer Institute, Charlotte
RECRUITING
Sylvester Comprehensive Cancer Center, Miami
RECRUITING
University of Chicago, Chicago
RECRUITING
UT Southwestern, Dallas
RECRUITING
MD Anderson Cancer Center, Houston
RECRUITING
City of Hope, Duarte
RECRUITING
Fred Hutchinson Cancer Center, Seattle
RECRUITING
UHN - Princess Margaret Cancer Centre, Toronto
Lead Sponsor
Iterion Therapeutics
INDUSTRY