Actively Recruiting
A Phase 1/2 Exploratory Study of the TBL1 Inhibitor, Tegavivint (BC2059), in Patients With Advanced Hepatocellular Carcinoma
Led by Iterion Therapeutics · Updated on 2025-07-04
178
Participants Needed
8
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating tegavivint, an investigational drug, in patients with advanced hepatocellular carcinoma (HCC) who have not responded to at least one prior systemic therapy. The study is divided into two parts: the first focuses on determining the best dose of tegavivint alone, and the second explores combinations of tegavivint with either cabozantinib or lenvatinib. This phase 1/2 study aims to find safe and effective dosing while monitoring patients closely for side effects and tumor responses. In the first part, tegavivint is given alone once weekly on days 1, 8, 15, and 22 of a 28-day cycle, following a dose escalation plan to find the maximum tolerated dose. After identifying two optimal doses, about 40 patients will be randomized to these doses for further evaluation. If results are promising, the second part begins with dose escalation for combinations of tegavivint plus cabozantinib or tegavivint plus lenvatinib, followed by dose expansions with about 12 patients per combination at the recommended doses. The combination drugs are given daily alongside weekly tegavivint within similar 28-day cycles. Participants will undergo tumor assessments at the start and every 8 weeks during treatment, with safety monitored up to 90 days after the last dose or new cancer therapy. The study includes detailed lab tests, biopsies, and evaluations of organ function before and during treatment. Researchers will track adverse events, dose-limiting toxicities, and tumor responses to understand how well tegavivint works alone and in combination. The total participation duration averages around one year, with ongoing safety and efficacy monitoring throughout this time.
CONDITIONS
Brief 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 by pathology or clinical criteria
- Barcelona Clinic Liver Cancer Stage C or B disease not suitable for curative or locoregional therapy
- Child-Pugh class A or B liver function with score 7 or less and no hepatic encephalopathy
- Disease progressed after, intolerant to, or contraindicated for at least one prior systemic therapy
- Measurable disease by RECIST 1.1 using CT or MRI
- Willing and able to provide tumor biopsies during screening and treatment
- ECOG performance status of 0 or 1 within 7 days before first dose
- Adequate organ and marrow function as specified in the protocol
- Completed required washout periods from prior anticancer treatments
- Grade 1 or lower toxicity from previous cancer therapies, except alopecia or peripheral neuropathy allowed at grade 2
- Controlled past hepatitis C or hepatitis B infection as defined
- Controlled blood pressure (≤150/90 mm Hg) with stable antihypertensive treatment if needed
You will not qualify if you...
- Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and HCC
- Receiving other antineoplastic or experimental agents
- Use of strong CYP3A4/5 inhibitors or inducers that cannot be stopped before starting study
- History of Gilbert's syndrome or genetic UGT1A1 disorders
- Allergic reactions to tegavivint or similar agents
- Other active cancers except certain treated skin or in situ cancers
- Lack of venous access or conditions interfering with drug administration or sample collection
- Central nervous system involvement
- Uncontrolled infections, unhealed wounds, or psychiatric/social conditions limiting compliance
- Significant uncontrolled heart disease or abnormal heart rhythm
- Major surgery within 21 days before starting study
- Pregnant or breastfeeding women
- Women and men who are sexually active with women of childbearing potential must use effective contraception
- HIV-positive on combination antiretroviral therapy
- For combination arms: large untreated esophageal varices, uncontrolled hypertension, severe proteinuria, recent significant bleeding or thrombotic events, QT/QTc prolonging medications, hypersensitivity to cabozantinib or lenvatinib as applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive tegavivint as a single agent or in combination with cabozantinib or lenvatinib in 28-day cycles.
Weekly visits during each 28-day cycle for tegavivint dosing; daily oral dosing of cabozantinib or lenvatinib as applicable.
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
G
Gilberto Botello
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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