A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Contact:

NCT Number:

Protocol:

AAAT9566

Study Status:

Active/Enrolling

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find out what dose of tegavivint should be used with children and how well it works when given to patients between the ages of 12 months to 30 years of age with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of children with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint will be given by vein on Day 1, Day 8, and Day 15 of 28 day cycle for up to 26 cycles, which will last about 24 months.

Are you Eligible? (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.
  • 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.

Specialty Area(s)

Lymphoma, Non-Hodgkin's Lymphoma, Sarcomas (Bone and Soft Tissue), Ewing's Sarcoma, Osteosarcoma, Childhood and Adolescent Cancers (Pediatric)

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032