147 Participants Needed

Tegavivint for Recurrent or Refractory Cancer

Recruiting at 22 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SB

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

I have a tumor that cannot be removed by surgery or is dangerous, and it can be measured.
I have a tumor that cannot be removed by surgery or is serious enough to consider treatment.
I have had a stem cell infusion, with or without full-body radiation.
See 12 more

Exclusion Criteria

Patients who are currently receiving another investigational drug are not eligible
I do not have a known metabolic bone disease.
Patients who have received a prior solid organ transplantation are not eligible
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

24 months
3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

12 months
Every 3 months

Long-term Follow-up

Participants are monitored annually for long-term safety and effectiveness

60 months
Annually

What Are the Treatments Tested in This Trial?

Interventions

  • Tegavivint
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (tegavivint)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials
467
Recruited
241,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

For patients with relapsed or progressive non-small cell lung cancer (NSCLC), treatment options are limited after conventional chemotherapy, with only erlotinib and crizotinib approved as third-line therapies in the U.S.
The review emphasizes the importance of identifying molecular characteristics of tumors to improve the effectiveness of targeted therapies, suggesting that agents affecting multiple pathways may offer significant clinical benefits.
Targeted agents in the third-/fourth-line treatment of patients with advanced (stage III/IV) non-small cell lung cancer (NSCLC).Langer, CJ., Mok, T., Postmus, PE.[2022]
In a report involving 3 pediatric patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma (ALCL), all patients achieved a complete response after treatment with ALK inhibitors.
Both crizotinib and alectinib demonstrated significant effectiveness in treating refractory ALK-positive ALCL in children, including one patient with central nervous system involvement.
Treatment of Relapsed and Refractory ALK-Positive Anaplastic Large Cell Lymphoma With ALK-Specific Tyrosine Kinase Inhibitor in Children: A Case Series.Shen, D., Song, H., Zhang, J., et al.[2023]
A lung cancer patient developed an ALK I1171T resistance mutation after treatment with chemotherapy and ALK inhibitors, highlighting the need to investigate resistance mechanisms in clinical practice.
Despite initial ineffectiveness, ceritinib was effective after whole-brain radiotherapy and shunting, suggesting that identifying resistance mutations can help optimize treatment strategies.
Ceritinib Treatment for Carcinomatous Meningitis with a Secondary Mutation at I1171T in Anaplastic Lymphoma Kinase.Ashinuma, H., Shingyoji, M., Hasegawa, Y., et al.[2019]

Citations

Targeted agents in the third-/fourth-line treatment of patients with advanced (stage III/IV) non-small cell lung cancer (NSCLC). [2022]
Treatment of Relapsed and Refractory ALK-Positive Anaplastic Large Cell Lymphoma With ALK-Specific Tyrosine Kinase Inhibitor in Children: A Case Series. [2023]
Ceritinib Treatment for Carcinomatous Meningitis with a Secondary Mutation at I1171T in Anaplastic Lymphoma Kinase. [2019]
Vinorelbine-based salvage therapy in HER2-positive metastatic breast cancer patients progressing during trastuzumab-containing regimens: a retrospective study. [2021]
The ALK/ROS1 Inhibitor PF-06463922 Overcomes Primary Resistance to Crizotinib in ALK-Driven Neuroblastoma. [2022]
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