Actively Recruiting
A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma
Led by Iterion Therapeutics · Updated on 2025-07-04
178
Participants Needed
8
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years of age or older
- Confirmed diagnosis of hepatocellular carcinoma (HCC) by pathology report or clinical criteria
- Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B disease not suitable for or refractory to locoregional therapy and not curable
- Child-Pugh class A or class B liver score of 7 or less without hepatic encephalopathy within 7 days before first dose
- Disease progression, intolerance, or contraindication to at least one prior systemic therapy for advanced HCC
- Measurable disease by RECIST 1.1 using CT or MRI scans
- Willing and able to provide tumor biopsies during screening and treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before first dose
- Adequate organ and marrow function within 7 days before first dose, including specified blood counts, liver enzymes, renal function, albumin, and INR
- Washout periods from prior treatments as specified (21 days for systemic anticancer therapy, 14-28 days for radiotherapy or local therapy)
- Grade 1 or less toxicity from prior cancer treatments (grade 2 allowed for alopecia or peripheral neuropathy)
- Past hepatitis C virus infection treated and viral load below detection
- Controlled hepatitis B virus infection meeting defined criteria
- Controlled blood pressure of 150/90 mm Hg or lower with stable antihypertensive treatment
You will not qualify if you...
- Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Receiving other anti-cancer or experimental agents
- Use of strong CYP3A4/5 inhibitors or inducers that cannot be stopped before treatment
- Known Gilbert's syndrome or genetic conditions affecting UGT1A1 function
- History of allergic reactions to tegavivint or related agents
- Other malignant diseases except certain treated skin cancers or indolent malignancies without recent recurrence
- Lack of venous access or conditions interfering with treatment or sample collection
- Known central nervous system involvement
- Uncontrolled illnesses including active infections or unhealed wounds
- Significant uncontrolled heart disease or cardiac abnormalities as detailed
- Major surgery within 21 days before treatment start
- Pregnant or breastfeeding women
- Women of child-bearing potential and sexually active men must use effective contraception during and for 4 months after treatment
- HIV-positive patients on combination antiretroviral therapy
- For cabozantinib or lenvatinib arms: untreated large esophageal varices, uncontrolled hypertension, severe proteinuria, recent significant bleeding, recent thrombotic events, use of QT prolonging drugs, hypersensitivity to study drugs as specified
AI-Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
5
UT Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98133
Actively Recruiting
8
UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Actively Recruiting
Research Team
R
Rose Hernandez
CONTACT
G
Gilberto Botello
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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