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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

Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a creatinine based on age/gender as follows (within 7 days prior to enrollment):

PART A: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment

Must not have

Patients with a known metabolic bone disease (ex: hyperparathyroidism, Paget's disease, osteomalacia) are not eligible

Patients with known central nervous system (CNS) metastasis, except for craniopharyngeal tumors, will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

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.

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.

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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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 am between 12 months and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a known metabolic bone disease.

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I do not have brain metastasis, except for craniopharyngeal tumors.

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I am not taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I do not have any infections that are not under control.

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My calcium levels are normal or can be corrected with oral supplements.

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I do not have a condition that affects how my bones process minerals.

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I do not have severe osteoporosis.

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I have not taken denosumab in the last 6 months.

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I do not have a primary brain tumor.

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I am not taking any strong medication that affects enzyme CYP3A4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the drug concentration curve of tegavivint

Frequency of adverse events attributable to tegavivint

Frequency of dose limiting toxicities of tegavivint

Secondary study objectives

Antitumor effects of tegavivint in patients with solid tumors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2020

Dual X-ray Absorptiometry

2015

N/A

~50