Recruiting nowPhase 2
What this trial is trying to do
The researchers think tegavivint may slow tumour growth by interfering with beta-catenin’s binding to TBL1, disrupting internal growth signals in cancer cells. The trial is testing its dosing and safety, along with any signs of benefit, in recurrent or treatment-resistant solid tumours, lymphomas and desmoid tumours.
The idea is that blocking this growth pathway could control cancers that have returned or no longer respond to treatment. The main measure is dose-limiting toxicity—side effects that prevent giving more drug—so the immediate goal is to find a tolerable dose rather than show longer survival or longer control of the cancer.
Worth knowing: This is a non-randomised phase I/II trial, and its main outcome is safety rather than a comparison of survival or tumour control with standard treatment.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT04851119 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 147 people (planned) |
| Who can join | aged 12 Months to 30 Years |
| Run by | Children's Oncology Group |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Biospecimen Collection
- Procedure Dual X-ray Absorptiometry
- Drug Tegavivint
- Procedure X-Ray Imaging
What it is measuring
Frequency of dose limiting toxicities of tegavivint
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- PART A: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
- PART B: Patients must be >= 12 months and =< 30 years of age at the time of study enrollment
- Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse
- PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors
- PART B: Patients with recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations. For the Wnt pathway aberrations cohort we will include the most common CTNNB1 mutations (S37F, S45F, T41A, S45P, S33C, S37C, D32Y, S33F, T41I, G34R, G34V, D32N, S33P, G34E, D32G) as well as any loss of function mutations in the APC, Axin2FBXW7, TCF7L2, and RNF43 genes or any gain-of-function mutations in the GSK3B, LRP6, and LGR5 genes. For patients without prior sequencing, immunohistochemistry (IHC), is required.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 21 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04851119, registered by Children's Oncology Group on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.