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Trials / Recruiting

RecruitingNCT04851119

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
147 (estimated)
Sponsor
Children's Oncology Group · Network
Sex
All
Age
12 Months – 30 Years
Healthy volunteers
Not accepted

Summary

This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of tegavivint administered as an intravenous (IV) infusion over 4 hours, once weekly for 3 weeks, followed by a 1 week rest, in a 28-day cycle to pediatric patients with recurrent/refractory solid tumors, including non-Hodgkin lymphoma and desmoid tumors. (Phase 1 Dose Escalation) II. To preliminarily define antitumor activity of tegavivint in pediatric patients with recurrent or refractory Ewing sarcoma, liver tumors (hepatocellular carcinoma \[HCC\] and hepatoblastoma), osteosarcoma, Wilms tumor, desmoid tumors, and tumors with Wnt pathway aberrations. (Phase 2) III. To define and describe the toxicities of tegavivint administered on this schedule. (Phase I) IV. To characterize the pharmacokinetics of tegavivint in pediatric patients with recurrent or refractory cancer. (Phase I) SECONDARY OBJECTIVE: I. To preliminarily define the antitumor activity of tegavivint for pediatric patients with recurrent/refractory solid tumors, including lymphoma and desmoid tumors within the confines of a Phase 1 study. EXPLORATORY OBJECTIVES: I. To test whether baseline activity of the WNT/beta catenin pathway correlates with clinical response using archived tumor tissue. II. To characterize pharmacodynamic changes in tumor tissue to examine target engagement by tegavivint. III. To characterize pharmacodynamic activity of tegavivint on serum protein biomarkers. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive tegavivint IV over 4 hours on days 1, 8, and 15 of each cycle. Treatment repeats every 28 days for up to 26 cycles or 24 months in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray at baseline, after cycle 1, and then every 3 cycles while on treatment and a dual x-ray absorptiometry (DEXA) scan at baseline, every 6 cycles while on treatment, at months 12 and 24, and then annually up to 60 months following end of therapy. Patients may also undergo blood sample collection throughout the trial. After completion of study intervention, patients are followed up every 3 months for 12 months, every 6 months for 24 months, and then annually for 60 months.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREDual X-ray AbsorptiometryUndergo DEXA scan
DRUGTegavivintGiven IV
PROCEDUREX-Ray ImagingUndergo x-ray imaging

Timeline

Start date
2021-11-08
Primary completion
2028-06-30
Completion
2028-06-30
First posted
2021-04-20
Last updated
2026-02-24

Locations

21 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04851119. Inclusion in this directory is not an endorsement.