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Hepatocellular Carcinoma (HCC)Phase 1/2NCT07878689

Study of Tegavivint Plus Zanzalintinib in Patients With Advanced Hepatocellular Carcinoma

A Phase 1/2 study testing Zanzalintinib and Tegavivint in people with Hepatocellular Carcinoma (HCC), run by University of Texas Southwestern Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the combination of zanzalintinib (XL092) and tegavivint in advanced hepatocellular carcinoma (HCC) and Wnt pathway mutations who have progressed after at least one prior line of systemic therapy and are naïve (not previously treated with) standard of care tyrosine kinase… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Zanzalintinib and Tegavivint
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 1 Dec 2029
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
  • Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection
  • 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
Show all 34Show fewer
  • Documented alteration in the Wnt/β-catenin pathway (CTNNB1, AXIN1, CREBBP, or APC) in tumor tissue or circulating tumor DNA (ctDNA), determined by a next-generation sequencing assay performed in a CLIA-certified or equivalent laboratory. Local or central testing is acceptable, including testing performed as part of standard of care before screening. This requirement applies to participants enrolled in both the dose escalation and the dose expansion parts of the study.
  • Disease progression, intolerance or contraindication to at least one line of systemic therapy for advanced HCC eligible for immune checkpoint inhibitors. Participants who are ineligible for immune checkpoint inhibitors do not require prior treatment
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to the first dose of the investigational product(s)
  • Participants must have organ and marrow function as defined below during screening and performed by local laboratories within 14 days of the first dose of the investigational product(s):
  • Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection.
  • Platelets ≥ 75 x 109/L; no transfusion within 7 days prior to the screening laboratory assessment
  • Hemoglobin ≥ 10 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 ≤ 1 x ULN
  • AST and ALT ≤ 5 x ULN; for participants with documented bone metastasis ALP ≤ 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 Note: If estimated CrCl or eGFR is abnormal, accurate measurement may be obtained by 24-hour urine collection to measure creatinine clearance.
  • Urine Protein Creatinine Ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol)
  • Albumin ≥ 2.8 g/dL
  • International normalized ratio (INR) ≤ 1.7
  • Grade ≤ 1 toxicity due to any previous cancer therapy according to the NCI-CTCAE, v.5. (excluding alopecia and clinically stable toxicities that will not interfere with study procedures according to the treating investigator that may or may not requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment)
  • Participants with past HCV infection will be eligible for the study. Participants who received HCV treatment 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 2 weeks and HBV viral load must be less than 500 IU/mL prior to first dose of study drug. Participants on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout study intervention.
  • Participants 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.
  • Participants must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 140/90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1 Day
  • All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for the following durations following completion of therapy: through 186 days after the last dose of zanzalintinib or tegavivint for women of childbearing potential or through 96 days after the last dose of zanzalintinib or tegavivint for men, see Appendix A2. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Ability to understand and the willingness to sign a written informed consent.

Who cannot join

  • HCC-Specific
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  • Known central nervous system (CNS) involvement.
  • Known gastric or esophageal varices.
  • Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks.
  • Documented hepatic encephalopathy (HE) within 6 months before first dose of study treatment.
Show all 55Show fewer
  • Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before first dose of study treatment.
  • Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).
  • Tumors invading the GI-tract from external viscera
  • Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Participants with lesions invading the hepatic portal vasculature are eligible.
  • Prior and Concomitant Treatment
  • Prior treatment with a VEGFR-TKI or tegavivint is not allowed.
  • Participants receiving therapy with other anti-neoplastic or experimental agents.
  • Participants who have not recovered from clinically significant adverse events of their most recent prior anticancer therapy or intervention to NCI-CTCAE v5.0 Grade ≤ 1 or to baseline prior to the first dose of study treatment (excluding alopecia and clinically stable toxicities that will not interfere with study procedures according to the treating investigator, consistent with the inclusion criterion for recovery from prior cancer therapy). For participants previously treated with bevacizumab, the last dose of bevacizumab must be at least 27 days before the first dose of study treatment.
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment.
  • Participants who have received any prior local anticancer therapy including surgery, PEI, RFA, MWA, transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose of study treatment.
  • Participants 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.
  • Participants receiving concomitant inducers of CYP3A4/5 that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.
  • Participants on treatment with medications with a high potential to prolong the QT/QTc interval.
  • Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following: (a) Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH). (b) Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: participants must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.
  • Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
  • Cardiovascular
  • Clinically significant, unstable or deteriorating cardiovascular disorders:
  • Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).
  • Left ventricular ejection fraction < 50%
  • Prior history of myocarditis
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction, or other clinically significant arterial thrombotic and/or ischemic event within 6 months before first dose of study treatment.
  • Clinically significant pericardial disease
  • Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment. Note: participants with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen. Note: participants who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.
  • Baseline QTc (Fridericia) > 480 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.
  • Gastrointestinal Disorders
  • Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.
  • Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause definitively managed and patient asymptomatic.
  • Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.
  • Malabsorption syndrome.
  • Bleeding
  • Clinically significant hematuria, hematemesis, or hemoptysis of >0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding within 12 weeks before first dose of study treatment.
  • Other Medical Conditions
  • Ongoing or active infection requiring systemic treatment (exception: HBV infection - see inclusion criteria). Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.
  • Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for PK interactions with tegavivint.
  • Serious non-healing wound/ulcer/bone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions
  • Pharmacologically uncompensated, symptomatic hypothyroidism.
  • Requirement for hemodialysis or peritoneal dialysis.
  • History of solid organ or allogeneic stem cell transplant.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Participants with known history of Gilbert's syndrome or other genetic conditions affecting UGT1A1 function.
  • Surgical and Procedural
  • Major surgery (eg, GI surgery, removal or biopsy of brain metastasis, see Appendix B3) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (ie nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred prior to first dose of study treatment.
  • General
  • Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.
  • Pregnant and breastfeeding women are excluded from this study.
  • Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint, or other agents used in study.
  • Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carrie Manwaring, BS contact

214-648-7097

carrie.manwaring@UTSouthwestern.edu

United States1 site

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Carrie Manwaring, BS, 214-648-7097, carrie.manwaring@utsouthwestern.edu

Other trials in United States

About this study

Official title: A Phase 1/2 Study of Tegavivint Plus Zanzalintinib in Patients With Advanced Hepatocellular Carcinoma

The goal of this clinical trial is to evaluate the combination of zanzalintinib (XL092) and tegavivint in advanced hepatocellular carcinoma (HCC) and Wnt pathway mutations who have progressed after at least one prior line of systemic therapy and are naïve (not previously treated with) standard of care tyrosine kinase inhibitors targeting vascular endothelial growth factor signaling.

Read the detailed description

This Phase I/II investigator-sponsored trial will evaluate the combination of zanzalintinib (XL092) and tegavivint in participants with advanced hepatocellular carcinoma (HCC) and Wnt pathway mutations (CTNNB1, AXIN1, CREBBP, APC) who have progressed after at least one prior line of systemic therapy and are VEGFR-TKI naïve. The study employs a two-part design beginning with a Phase I dose escalation using a Bayesian Optimal Interval (BOIN) design with cohorts of 3-6 participants per dose level to determine the safety and tolerability of the combination. The dose escalation will evaluate tegavivint in combination with fixed-dose zanzalintinib. A maximum of 12 evaluable participants will be enrolled in the dose escalation phase to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of tegavivint when combined with zanzalintinib.

Being tested
Zanzalintinib, Tegavivint
Keywords
Wnt pathway mutations
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • ZanzalintinibDrug

    40 mg PO once daily

  • ZanzalintinibDrug

    60 mg PO once daily

  • TegavivintDrug

    Also called BC2059

    5 mg/kg IV weekly

  • TegavivintDrug

    Also called BC2059

    6.5 mg/kg IV weekly

Study groups in NCT07878689
Study groupRoleWhat they receive
Phase 1: Dose Escalation: Dose Level 2ExperimentalParticipants will receive tegavivint as an intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle at the dose level determined by the cohort assignment, combined with zanzalintinib 60 mg taken orally once daily on Days 1 through 28 of every cycle.
Receives: Drug: Zanzalintinib; Drug: Tegavivint
Phase 1: Dose Escalation: Dose Level 1ExperimentalStarting Dose Level Participants will receive tegavivint as an intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle at the dose level determined by the cohort assignment, combined with zanzalintinib 60 mg taken orally once daily on Days 1 through 28 of every cycle.
Receives: Drug: Zanzalintinib; Drug: Tegavivint
Phase 1: Dose Escalation: Dose Level -1ExperimentalParticipants will receive tegavivint as an intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle at the dose level determined by the cohort assignment, combined with zanzalintinib 60 mg taken orally once daily on Days 1 through 28 of every cycle.
Receives: Drug: Zanzalintinib; Drug: Tegavivint
Phase 2: Dose ExpansionExperimentalPhase 2, participants will be assigned to take zanzalintinib (XL092) and tegavivint at a dosage determine by Phase 1.
Receives: Drug: Zanzalintinib; Drug: Tegavivint

What is being measured

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

  1. Safety/Tolerability as measured by number of subjects with dose limiting toxicity

    Safety/Tolerability is measured by the number of participants treated with different dose levels of tegavivint in combination with zanzalintinib who experience dose limiting toxicity adverse events (AE) >= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0.

    Measured: First administration of tegavivint in combination with zanzalintinib up to 24 months

  2. Determine Maximum Tolerated Dose (MTD)

    To estimate the MTD and/or to identify the recommended dose of tegavivint for combination zanzalintinib, the variable is the incidence of DLTs in the first cycle of treatment. Estimation of the MTD(s)/recommended dose(s) will be based on a BOIN dose escalation design and dose expansion to estimate the probability of DLT in the first cycle of treatment for participants in the DDS. Following completion of the combination dose escalation, all safety,

    Dose-determining analysis set (DDS) The DDS includes all participants from the safety set who either completed a minimum exposure requirement or who had a DLT during the first cycle of treatment. The minimum exposure requirement is defined as having received ≥ 80% of the intended tegavivint + zanzalintinib dose(s) during the first cycle.

    Measured: First administration of tegavivint in combination with zanzalintinib to the end of Cycle 1 (each cycle is 28 days).

  3. Recommended phase 2 dose (RP2D) of tegavivint in combination with zanzalintinib

    To determine the recommended phase 2 dose (RP2D) of tegavivint in combination with zanzalintinib.

    The dose determining set will include all participants who either completed a minimum exposure requirement or who had a DLT during the first cycle of treatment. The minimum exposure requirement is defined as having received ≥ 80% of the intended tegavivint + zanzalintinib dose(s) during the first cycle.

    The RP2D of tegavivint in combination with zanzalintinib will be determined by toxicity assessed by NCI CTCAE v5.0 toxicity criteria.

    Measured: First administration of tegavivint in combination with zanzalintinib to 24 months

Secondary outcomes (7)

  1. Frequency and severity of adverse events

    To determine the frequency and severity of adverse events as assessed by NCI CTCAE version 5.

    Measured: Initial treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

  2. Overall Response Rate (ORR)

    To determine the overall response rate of combination tegavivint plus zanzalintinib based on Investigator assessment, per RECIST v.1.1.

    The objective response rate is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). ORR and its 95% confidence intervals will be summarized.

    BOR for each patient is determined from the assessment of response for overall tumor lesions according to the following rules:

    • CR = at least two determinations of CR at least 1 cycle apart before progression
    • PR = at least two determinations of PR or better at least 1 cycle apart before progression (and not qualifying for a CR)
    • SD = stable disease for > 4 cycles (±14 days) after Cycle 1 Day 1 (and not qualifying for CR or PR)
    • PD = progression < 4 cycles after Cycle 1 Day 1 (and not qualifying for CR, PR or SD)

    Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

  3. Disease Control Rate (DCR)

    To determine the disease control rate of combination tegavivint plus zanzalintinib based on Investigator assessment, per RECIST v.1.1.

    The disease control rate is defined as defined as the proportion of participants with BOR of CR or PR or SD.

    BOR for each patient is determined from the assessment of response for overall tumor lesions according to the following rules:

    • CR = at least two determinations of CR at least 1 cycle apart before progression
    • PR = at least two determinations of PR or better at least 1 cycle apart before progression (and not qualifying for a CR)
    • SD = stable disease for > 4 cycles (±14 days) after Cycle 1 Day 1 (and not qualifying for CR or PR)
    • PD = progression < 4 cycles after Cycle 1 Day 1 (and not qualifying for CR, PR or SD)

    Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

  4. Duration of response (DOR)

    To evaluate efficacy of tegavivint plus zanzalintinib by RECIST 1.1 in participants by DOR.

    DOR only applies to participants whose BOR is CR or PR.

    BOR for each patient is determined from the assessment of response for overall tumor lesions according to the following rules:

    • CR = at least two determinations of CR at least 1 cycle apart before progression
    • PR = at least two determinations of PR or better at least 1 cycle apart before progression (and not qualifying for a CR)
    • SD = stable disease for > 4 cycles (±14 days) after Cycle 1 Day 1 (and not qualifying for CR or PR)
    • PD = progression < 4 cycles after Cycle 1 Day 1 (and not qualifying for CR, PR or SD)

    Measured: Date of first documented response of CR or PR, whichever is first recorded, and the end date is defined as the date of the first document progression (taking as reference for progressive disease the smallest measurements recorded since to 24 months.

  5. Time to response (TTR)

    To evaluate preliminary efficacy of tegavivint plus zanzalintinib by RECIST 1.1 in participants by TTR.

    TTR is defined as the time from Cycle 1 Day 1 to the first documented response, CR or PR (whichever is first recorded), which must be subsequently confirmed.

    Measured: Cycle 1 Day 1 to the end of Cycle 1 (each cycle is 28 days).

  6. Progression-free survival (PFS)

    Progression-free survival (PFS) PFS will be defined as the duration of time from start of the investigational product to the date of first documented disease progression, whichever occurs first.

    Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

  7. Overall survival (OS)

    To determine the overall survival rate of response assessed by RECIST guidelines (version 1.1)

    OS will be defined as the duration of time from start of the investigational product until date of death due to any cause. OS will be collected for all participants who start treatment.

    Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months

Timeline

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

  1. First posted16 Oct 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2029 (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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07878689
Sponsor's protocol ID
STU20261529
Status last verified
Oct 2026
First submitted
22 Sep 2026
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Zanzalintinib and Tegavivint in people with Hepatocellular Carcinoma (HCC), run by University of Texas Southwestern Medical Center at 1 site in United States.

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 34 inclusion and 55 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 Carrie Manwaring, BS (214-648-7097, carrie.manwaring@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety/Tolerability as measured by number of subjects with dose limiting toxicity (time frame: First administration of tegavivint in combination with zanzalintinib up to 24 months). 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 NCT07878689.

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 16 Oct 2026.

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