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

ConditionsColorectal CarcinomaEndometrial CarcinomaMelanomaNeuroblastomaOvarian CarcinomaPancreatic Ductal AdenocarcinomaRecurrent Desmoid FibromatosisRecurrent Ewing SarcomaRecurrent HepatoblastomaRecurrent Hepatocellular CarcinomaRecurrent Malignant Solid NeoplasmRecurrent Non-Hodgkin LymphomaRecurrent OsteosarcomaRefractory Desmoid FibromatosisRefractory Ewing SarcomaRefractory HepatoblastomaRefractory Hepatocellular CarcinomaRefractory Malignant Solid NeoplasmRefractory Non-Hodgkin LymphomaRefractory OsteosarcomaSolid Pseudopapillary Neoplasm of the PancreasWilms Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-30
SponsorChildren's Oncology Group

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant or breast-feeding women will not be entered on this study because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control

Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid

Patients who are currently receiving another investigational drug are not eligible

Patients who are currently receiving other anti-cancer agents are not eligible

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Dual X-ray Absorptiometry

    Procedure/Surgery

    Undergo DEXA scan

  • Tegavivint

    Drug

    Given IV

  • X-Ray Imaging

    Procedure/Surgery

    Undergo x-ray imaging

Treatment groups

147 Participants
are divided into 1 treatment group
Group A: Treatment (tegavivint)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Frequency of dose limiting toxicities of tegavivint

The number of patients experiencing a cycle 1 dose limiting toxicity at least possibly attributable to tegavivint by study part and dose level.

Time frame
Up to 28 days
2

Frequency of adverse events attributable to tegavivint

The number of patients experiencing adverse events that are at least possibly attributable to tegavivint by study part and dose level.

Time frame
Up to 60 months
3

Area under the drug concentration curve of tegavivint

The median (minimum \[min\], maximum \[max\]) of the area under the drug concentration curve for tegavivint by study part and dose level.

Time frame
Up to 2 days

Secondary outcomes

1

Antitumor effects of tegavivint in patients with solid tumors

Number of solid tumor patients with at least partial response to tegavivint at the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) stratified by study part and disease cohort.

Time frame
Up to 336 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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