RecruitingAdvanced Hepatocellular Carcinoma
A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Iterion Therapeutics
You may qualify if…
- ✓ Male or female, 18 years of age or older
- ✓ Confirmed diagnosis of HCC by either:
- ✓ Histologically or cytologically documented HCC based on pathology report or Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria
- ✓ Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach
- ✓ Child-Pugh class A or ≤ 7 class B liver score (no hepatic encephalopathy) within 7 days of first dose of the investigational product(s)
- ✓ Disease progression, intolerance or contraindication to at least one line of systemic therapy for advanced HCC Prior treatment with cabozantinib or lenvatinib is allowed in the combination dose escalation and expansion parts of the study.
- ✓ Measurable disease as defined by RECIST 1.1 with spiral computerized tomography (CT) scan or magnetic resonance imaging (MRI). Lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if progression has been demonstrated in such lesions.
- ✓ Willingness and ability to provide tumor biopsies during screening and while on treatment.
You may not qualify if…
- ✕ Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- ✕ Patients receiving therapy with other anti-neoplastic or experimental agents
- ✕ Patients receiving concomitant strong inhibitors of CYP3A4/5 that cannot be discontinued 7 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- ✕ Patients receiving concomitant inducers of CYP3A4/5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.
- ✕ Patients with known history of Gilbert's syndrome or other genetic conditions affecting UGT1A1 function.
- ✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint, or other agents used in study
- ✕ Malignant disease, other than that being treated in this study. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy.
- ✕ Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
Where it's recruiting
California
Duarte
Florida
Miami
Illinois
Chicago
North Carolina
Charlotte
Texas
Dallas · Houston
Washington
Seattle
Source: ClinicalTrials.gov · NCT05797805 · last updated 2025-07-04