Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Wnt pathway mutations

Outcome Measures

Primary Outcomes (3)

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.
First administration of tegavivint in combination with zanzalintinib up to 24 months
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.
First administration of tegavivint in combination with zanzalintinib to the end of Cycle 1 (each cycle is 28 days).
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.

Secondary Outcomes (7)

Frequency and severity of adverse events
Initial treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Overall Response Rate (ORR)
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Disease Control Rate (DCR)
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Duration of response (DOR)
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.
Time to response (TTR)
Cycle 1 Day 1 to the end of Cycle 1 (each cycle is 28 days).

Study Arms (4)

Phase 1: Dose Escalation: Dose Level 2

EXPERIMENTAL

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.

Drug: ZanzalintinibDrug: Tegavivint

Phase 1: Dose Escalation: Dose Level 1

EXPERIMENTAL

Starting 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.

Drug: ZanzalintinibDrug: Tegavivint

Interventions

ZanzalintinibDrug

40 mg PO once daily

Phase 1: Dose Escalation: Dose Level -1Phase 2: Dose Expansion

ZanzalintinibDrug

60 mg PO once daily

Phase 1: Dose Escalation: Dose Level 1

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, 18 years of age or older
Confirmed diagnosis of HCC by either:

Sponsors & Collaborators

Iterion Therapeutics
Industrycollaborator
Exelixis
Industrycollaborator
University of Texas Southwestern Medical Center

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Carrie Manwaring, BSCONTACT214-648-7097 carrie.manwaring@utsouthwestern.edu

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

David Hsieh, MD
University of Texas Southwestern Medical Center
PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie Manwaring, BS

CONTACT

214-648-7097 carrie.manwaring@UTSouthwestern.edu

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor, Internal Medicine

Study Record Dates

First Submitted

September 22, 2026

First Posted

October 16, 2026

Study Start

December 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 1, 2028

Study of Tegavivint Plus Zanzalintinib in Patients With Advanced Hepatocellular Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (4)

Phase 1: Dose Escalation: Dose Level 2

Phase 1: Dose Escalation: Dose Level 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Phase 1: Dose Escalation: Dose Level -1

Phase 2: Dose Expansion

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (4)

Phase 1: Dose Escalation: Dose Level 2

Phase 1: Dose Escalation: Dose Level 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Phase 1: Dose Escalation: Dose Level -1

Phase 2: Dose Expansion

You may not qualify if:

Data Sharing

Source record

Locations