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Advanced Hepatocellular CarcinomaPhase 1/2NCT05797805

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

A Phase 1/2 study testing Tegavivint, Lenvatinib and Cabozantinib in people with Advanced Hepatocellular Carcinoma, run by Iterion Therapeutics at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
Tegavivint, Lenvatinib and Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
8 sitesin 2 countries
Study dates
13 Sep 2023to Jun 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of the investigational product(s)
  • Patients must have organ and marrow function as defined below within 7 days of the first dose of the investigational product(s):
  • Absolute neutrophil count (ANC) ≥ 1.2 x 109/L
  • Platelets ≥ 60 x 10^9/L; no transfusion within 7 days prior to assessment
  • Hemoglobin ≥ 9 g/dL (red blood cell transfusion or growth factors support is not allowed in the 14 days prior to the screening laboratory assessment)
  • Total bilirubin ≤ ULN
  • AST and ALT ≤ 5 x ULN
  • Renal Function : Estimated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault equation using actual body weight, or Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min/1.73m2 by CKD-EPI Creatinine Equation, or Measured creatinine clearance ≥ 50 mL/min
  • Albumin ≥ 2.8 g/dL
  • International normalized ratio (INR) ≤ 1.7, unless the patient is receiving anticoagulant therapy as long as the patient is within therapeutic range of intended use of anticoagulants
  • Washout period prior to Day 1 of Cycle 1:
  • At least 21 days from the last dose of prior systemic anticancer treatment
  • At least 14 days from palliative radiotherapy (≤ 10 fractions or ≤30 gray [Gy] total dose or at least 28 days from radiotherapy > 30 Gy) to extrahepatic tumor lesions
  • At least 28 days from local or loco-regional therapy of intrahepatic tumor lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
  • Grade ≤ 1 toxicity due to any previous cancer therapy according to the NCI-CTCAE, v.5. Grade 2 is allowed in case of alopecia and/or peripheral sensory neuropathy.
  • Participants with past HCV infection will be eligible for the study. The treated participants must have completed their treatment at least 1 month prior to starting study intervention and HCV viral load must be below the limit of quantification.
  • Participants with controlled HBV will be eligible if they meet the following criteria:
  • Antiviral therapy for HBV must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to first dose of study drug. Patients on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout study intervention.
  • Patients who are positive for anti-hepatitis B core antibody HBc, negative for hepatitis B surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody (HBs), and who have an HBV viral load under 100 IU/mL, do not require HBV antiviral prophylaxis.
  • Patients must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150/90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1.

Who cannot join

  • 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
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  • 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
  • Known central nervous system (CNS) involvement
  • Uncontrolled concurrent illness including, but not limited to:
  • Ongoing or active infection (exception: HBV infection - see inclusion criteria)
  • Unhealed wounds or presence of any external drainage
  • Psychiatric illness/social situations that would limit compliance with study requirements; discuss with Medical Monitor if there are any questions
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
  • Congestive heart failure, NYHA > Class II
  • Left ventricular ejection fraction < 50%
  • Unstable angina pectoris or cardiac arrhythmia
  • Baseline QTc (Fridericia) ≥ 450 milliseconds. In the event a QTc (Fridericia) measurement is not possible due to factors such as a pacemaker or bundle branch block, the patient may be evaluated by a cardiologist who must document no apparent increased risk for Torsades de Point or other morbidity associated with prolonged QTc. With such documentation, the patient may be eligible based with additional Medical Monitor review.
  • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome
  • Myocardial infarct within 6 months before Cycle 1 Day 1
  • Clinically significant pericardial disease
  • Any major surgery within 21 days prior to Cycle 1 Day 1. Major surgery is defined as any significantly invasive procedure into a major body cavity (abdomen, cranium etc.) and/or surgery requiring extensive recuperation (joint replacement). Please discuss with the Medical Monitor if there are any questions.
  • Pregnant and breastfeeding women are excluded from this study. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with tegavivint
  • Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one highly effective method of contraception, including hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstaining from sex for the duration of study participation and for at least 4 months following completion of tegavivint and pembrolizumab (if applicable) administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for PK interactions with tegavivint.
  • Exclusions for patients treated on study with cabozantinib or lenvatinib:
  • Patients with large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of esophageal varices for patients in whom conventional medical intervention for known esophageal varices is already in place should be performed by endoscopy as per local standard of care.
  • Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg despite optimal medical management).
  • Persistent proteinuria of NCI-CTCAE version 5.0 grade 3 or higher. Urine dipstick result of 3+ is allowed if protein excretion (estimated by urine protein/creatinine ratio on a random urine sample) is <3.5 g/24 hours.
  • Clinically significant bleeding NCI-CTCAE version 5.0 grade ≥ 3 within 30 days before randomization.
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months before the start of study medication.
  • Patients treated with medications with a known potential to prolong the QT/QTc interval.
  • Hypersensitivity or intolerance to cabozantinib (patients with hypersensitivity or intolerance to cabozantinib may enroll in treatment arms exploring tegavivint plus lenvatinib if they did not have hypersensitivity or intolerance to lenvatinib).
  • Hypersensitivity or intolerance to lenvatinib (patients with hypersensitivity or intolerance to lenvatinib may enroll in treatment arms exploring tegavivint plus cabozantinib if they did not have prior hypersensitivity or intolerance to cabozantinib)

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Rose Hernandez contact

832-721-5208

rose@iteriontx.com

Gilberto Botello contact

gilberto@iteriontx.com

8 sites in 2 countries

United States7 sites, 7 recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Kelly Bumgarner, Kelly.Bumgarner@atriumhealth.org

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Asha Woodfolk, asha.woodfolk@uchicagomedicine.org

    Recruiting

  • UT Southwestern

    Dallas, Texas, 75390

    Ashley Bird, ashley.bird@utsouthwestern.edu

    Shazeb Munawar, 214-645-9883, Shahzeb.munawar@utsouthwestern.edu

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Amro Tahoun, 626-218-0115, amtahoun@coh.org

    Edwin Smura, 626-218-0115, esmura@coh.org

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Z. Esra Cobanoglu, ZECobanoglu@mdanderson.org

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Lauren Miro, lem183@med.miami.edu

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98133

    Sonia Wadhera, sgoyal@fredhutch.org

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • UHN - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G2M9

    Ama Chandrasiri, ama.chandrasiri@uhn.ca

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 1/2 Exploratory Study of the TBL1 Inhibitor, Tegavivint (BC2059), in Patients With Advanced Hepatocellular Carcinoma

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.

Read the detailed description

This study will be conducted in patients with advanced hepatocellular carcinoma (HCC) who have progressed after at least one prior line of systemic therapy.

Tegavivint will be administered as a single agent first in a dose escalation and optimization design. Single agent dose escalation will follow a standard 3+3 design to determine the tegavivint maximum tolerated dose (MTD). Upon completion of the dose escalation design and review of all available safety, efficacy, PK and PD data the Safety Review Committee (SRC) will recommend two dose levels for dose selection optimization. The dose selection optimization will expand the two dose levels to approximately 20 patients randomized (1:1) per dose level (approximately 40 patients total) before declaring the recommended phase 2 dose (RP2D).

If sufficient clinical benefit is observed, the combination of tegavivint plus cabozantinib and tegavivint plus lenvatinib will be explored in the second part of the study. The second part of the study will begin with a brief dose escalation part for each combination (tegavivint plus cabozantinib or tegavivint plus lenvatinib). The starting dose level of tegavivint will be decided by the SRC and will start at either one dose level below the MTD or at a lower dose as defined by the SRC. The dose escalations will follow a standard 3+3 design, and the dose escalation increments for tegavivint will follow the monotherapy dose escalation schedule to determine the combinations MTDs. Upon completion of the combination dose escalations, approximately 12 additional patients will be enrolled in each combination arm at the tegavivint combination MTDs.

Being tested
Tegavivint, Lenvatinib, Cabozantinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TegavivintDrug

    Also called BC2059

    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

  • LenvatinibDrug

    Also called Lenvima

    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 .

  • CabozantinibDrug

    Also called cabometyx

    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

Study groups in NCT05797805
Study groupRoleWhat they receive
Tegavivint single agent dosing regimenExperimentalTegavivint as monotherapy
Receives: Drug: Tegavivint
Tegavivint plus cabozantinib combination dosing regimenExperimentalTegavivint in combination with cabozantinib
Receives: Drug: Tegavivint; Drug: Cabozantinib
Tegavivint plus lenvatinib combination dosing regimenExperimentalTegavivint in combination with lenvatinib
Receives: Drug: Tegavivint; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Related Adverse Events

    Adverse events will be assessed according to the NCI-CTCAE version 5.0

    Measured: from the date of the first dose of study medication up to 90 days following last dose of study medication or initiation of new systemic anti-cancer therapy, whichever occurs first, an average of 1 year.

  2. Number of participants with dose limiting toxicities

    Dose limiting toxicities defined as a Grade 3 or greater adverse event as assessed by NCI-CTCAE version 5.0 (excluding toxicities clearly related to the underlying disease [HCC], disease progression, concomitant medications, or baseline concurrent medical conditions),and that meets any of the criteria included in Table 6-5.

    Measured: Within a 28-day period after first dose of the study medication as a single agent or in combination with cabozantinib or lenvatinib.

  3. Evaluate efficacy of tegavivint as a single agent

    Evaluate efficacy of tegavivint as a single agent in subjects with hepatocellular carcinoma as assessed by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

    Measured: Tumors will be assessed at baseline and every 8 weeks until end of treatment, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start13 Sep 2023
  3. Primary completionMay 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797805
Sponsor's protocol ID
ITER-002-HCC
Status last verified
Jul 2025
First submitted
8 Mar 2023
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tegavivint, Lenvatinib and Cabozantinib in people with Advanced Hepatocellular Carcinoma, run by Iterion Therapeutics at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rose Hernandez (832-721-5208, rose@iteriontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Related Adverse Events (time frame: from the date of the first dose of study medication up to 90 days following last dose of study medication or initiation of new systemic anti-cancer therapy, whichever occurs first, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.

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