PEPN2011: 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

Study category: Cancer

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Description

For Patients on Part A: D with a solid tumor, lymphoma or desmoid tumor that has either come back or does not respond to therapy, or a desmoid tumor that cannot be removed safely by surgery. For Patients on Part B: Diagnosed with a relapsed or refractory Ewing sarcoma, desmoid tumor, osteosarcoma, liver tumor (HCC and hepatoblastoma), Wilms tumor or tumors with changes in a gene family known as the Wnt pathway. The overall goals of this study are: - This is called a Phase 1/2 study because the goal is to find the highest safe dose of tegavivint that can be given without causing severe side effects - To learn what kind of side effects tegavivint may cause - To learn more about the pharmacology (how your body handles the drug) of tegavivint - To determine whether tegavivint is a beneficial treatment for your cancer The study will be testing different doses of the study drug tegavivint to find the safest dose. Up to 4 different doses of tegavivint may be studied.

Details
Age

Child to Adult

Eligibility

Age 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. Diagnosis: 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. Disease Status: Patients must have either measurable (Part B) or evaluable disease. Performance Level: Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients16 years of age. Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment.

Type of Study

Treatment

Locations

Childrens Hospital Colorado

Principal Investigator
Margaret Macy,  MD

Margaret Macy, MD

Study ID

Protocol Number: 21-4712

More information available at ClinicalTrials.gov: NCT04851119

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