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.
I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of
tegavivint administered as an 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)
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.
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
Patients receive tegavivint intravenously (IV) over 4 hours on days 1, 8, and 15. Treatment
repeats every 28 days for up to 26 cycles in the absence of disease progression or
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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