Tegavivint for Recurrent or Refractory Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before enrolling. You cannot be on other anti-cancer agents, investigational drugs, or medications that strongly affect the enzyme CYP3A4. If you are on corticosteroids, you must be on a stable or decreasing dose for at least 7 days before joining the trial.
What makes the drug Tegavivint unique for treating recurrent or refractory cancer?
Tegavivint is unique because it targets the TBL1 (Transducin Beta-Like Protein 1) pathway, which is different from many other cancer treatments that often target more common pathways like ALK or EGFR. This novel mechanism may offer a new option for patients whose cancers do not respond to existing therapies.12345
Who Is on the Research Team?
Sarah B Whittle
Principal Investigator
Pediatric Early Phase Clinical Trial Network
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tegavivint IV over 4 hours on days 1, 8, and 15 of each 28-day cycle, for up to 26 cycles or 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Long-term Follow-up
Participants are monitored annually for long-term safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Tegavivint
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator