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Beta-catenin/TBL1 Inhibitor

Tegavivint for Recurrent or Refractory Cancer

Phase 1 & 2
Recruiting
Led By Sarah B Whittle
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PART B: Patients must have measurable disease. For desmoid tumors, the patient must have measurable disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
PART A: Patients must have either measurable or evaluable disease. For desmoid tumors, the patient must have disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can stop the growth of cancer cells.

Who is the study for?
This trial is for young people aged up to 21 or 30 years with recurrent or refractory solid tumors, including lymphomas and desmoid tumors. They must have measurable disease, be recovered from previous cancer treatments, meet specific blood count criteria, and not have severe bone diseases or uncontrolled infections. Pregnant individuals can't participate and those of reproductive potential must use effective birth control.Check my eligibility
What is being tested?
The trial is testing Tegavivint's highest safe dose and its effects on patients with stubborn solid tumors that resist treatment. Tegavivint aims to block tumor growth by disrupting signals within cells that encourage cell proliferation.See study design
What are the potential side effects?
Possible side effects include reactions related to the disruption of cellular signaling which could affect organ function but specifics are not detailed in the provided information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that cannot be removed by surgery or is dangerous, and it can be measured.
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I have a tumor that cannot be removed by surgery or is serious enough to consider treatment.
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I have had a stem cell infusion, with or without full-body radiation.
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I have a solid tumor, non-Hodgkin lymphoma, or desmoid tumor that has not responded to treatment.
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My kidney function is good based on recent tests.
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I am between 12 and 21 years old.
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I have a confirmed diagnosis of a solid tumor, non-Hodgkin lymphoma, or desmoid tumor that has come back or did not respond to treatment.
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I have a specific type of cancer or genetic mutation listed for PART B.
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My bilirubin levels are within the normal range for my age.
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I have recovered from previous cancer treatments and meet the required health criteria.
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I can join the study if my blood counts are okay, even with bone marrow cancer.
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I am between 12 months and 30 years old.
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I can take care of myself but might not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the drug concentration curve of tegavivint
Frequency of adverse events attributable to tegavivint
Frequency of dose limiting toxicities of tegavivint
Secondary outcome measures
Antitumor effects of tegavivint in patients with solid tumors

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (tegavivint)Experimental Treatment4 Interventions
Tegavivint will be administered IV over 4 hours on days 1, 8, and 15 of each cycle. Administer D5W flush after completion of each tegavivint infusion. Treatment repeats every 28 days for up to 26 cycles or 24 months in the absence of disease progression or unacceptable toxicity. Drug doses should be adjusted based on the weight (height and BSA will also be captured) measured within 7 days prior to the beginning of each cycle. The starting dose will be 5 mg/kg with dose levels for subsequent cohorts increasing to 6.5 mg/kg and 8 mg/kg if excessive toxicity does not occur. If the MTD has been exceeded at the first dose level, then the subsequent cohort of patients will be treated at a dose of 4 mg/kg. Patients undergo an x-ray at baseline, after cycle 1, and then every 3 cycles while on treatment and DEXA scan at baseline and every 6 cycles while on treatment, then at 12 months, 24 months, and annually up to 60 months following end of therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Dual X-ray Absorptiometry
2015
N/A
~50
Tegavivint
2018
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,553 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,520 Total Patients Enrolled
75 Trials studying Endometrial Cancer
73,374 Patients Enrolled for Endometrial Cancer
Sarah B WhittlePrincipal InvestigatorPediatric Early Phase Clinical Trial Network

Media Library

Tegavivint (Beta-catenin/TBL1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04851119 — Phase 1 & 2
Endometrial Cancer Research Study Groups: Treatment (tegavivint)
Endometrial Cancer Clinical Trial 2023: Tegavivint Highlights & Side Effects. Trial Name: NCT04851119 — Phase 1 & 2
Tegavivint (Beta-catenin/TBL1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851119 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial taking place in more than one state?

"There are a number of hospitals participating in this trial, 20 in total. Some notable locations include Children's Hospital Colorado in Aurora, UCSF Medical Center-Mission Bay in San Francisco, and Children's Hospital of Alabama in Birmingham."

Answered by AI

For this particular test, are older individuals welcome to participate?

"According to the eligibility requirements, patients who wish to participate in this trial must be between 12 months and 30 years old. Out of the 11,076 total clinical trials taking place, 1,089 are for people under 18 while 9,187 are for those over 65."

Answered by AI

How many candidates will be allowed to enroll in the research?

"In order for this research to be conducted, 147 individuals that fit the pre-determined inclusion criteria must participate. These potential participants can be found at Children's Hospital Colorado in Aurora, Colorado and UCSF Medical Center-Mission Bay in San Francisco, California among other locations."

Answered by AI

Which type of person is this research looking for?

"This clinical trial is looking for 147 individuals that have been diagnosed with wilms tumor. The patients must be between 12 months and 30 years old, though there are different age requirements depending on which part of the study they hope to enroll in. Furthermore, candidates should meet one or more of the following criteria: having relapsed or refractory solid tumors (including non-Hodgkin lymphoma and desmoid tumors), being12 months to 21 years old at time of enrollment (for PART A), being recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors ("

Answered by AI

Are people still being accepted into the trial program?

"According to the information displayed on clinicaltrials.gov, this trial is still looking for participants. The study was first advertised on October 25th 2021 and was last updated September 22nd 2022. So far, 147 patients have been recruited from 20 different centres."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
~93 spots leftby Jun 2028