Tegavivint + Zanzalintinib for Liver Cancer

CM
Overseen ByCarrie Manwaring, BS
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

DH

David Hsieh, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced liver cancer (hepatocellular carcinoma) who have already tried at least one treatment but haven't received certain standard drugs called VEGF-targeting tyrosine kinase inhibitors. Participants should have specific gene changes in the Wnt pathway.

Inclusion Criteria

My liver function is normal or only mildly impaired.
I have advanced liver cancer that got worse or I can't take standard treatments.
Renal function with CrCl or eGFR ≥ 50 mL/min or measured creatinine clearance ≥ 50 mL/min
See 16 more

Exclusion Criteria

I have needed fluid drained from my abdomen, lungs, or heart in the past 4 weeks.
I have a rare type of liver cancer, not typical hepatocellular carcinoma.
My cancer has spread to my brain or spinal cord.
See 37 more

What Are the Treatments Tested in This Trial?

Interventions

  • Tegavivint
  • Zanzalintinib

Trial Overview

The study is testing a combination of two drugs, zanzalintinib and tegavivint, to see if they work together to treat advanced liver cancer. All participants will receive both medications.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Phase 2: Dose ExpansionExperimental Treatment2 Interventions
Group II: Phase 1: Dose Escalation: Dose Level 2Experimental Treatment2 Interventions
Group III: Phase 1: Dose Escalation: Dose Level 1Experimental Treatment2 Interventions
Group IV: Phase 1: Dose Escalation: Dose Level -1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Iterion Therapeutics

Industry Sponsor

Trials
2
Recruited
130+

Exelixis

Industry Sponsor

Trials
126
Recruited
20,500+
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Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

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Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD