Tegavivint for Treating Recurrent or Hard-to-Treat Solid Tumors, Including Lymphomas and Desmoid Tumors

Sponsor: Children's Oncology Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04851119

Provider View

This clinical trial is testing the safety and potential benefits of a new drug, tegavivint, for patients with solid tumors that have returned or are not responding to treatment. The study aims to find the highest safe dose and understand how the drug works in stopping tumor growth.

Patient Parameters

Program Overview

This study is exploring the use of tegavivint, a drug that may help stop the growth of tumor cells by blocking certain signals inside the cells. The trial is in two phases: Phase I will determine the safest dose and Phase II will assess the drug's effectiveness in shrinking tumors. The study involves patients with solid tumors that have come back or are not responding to treatment, including lymphomas and desmoid tumors. Participants will receive the drug through an IV infusion once a week for three weeks, followed by a week of rest, in a 28-day cycle. The treatment can continue for up to 26 cycles or 24 months unless the disease progresses or side effects become unacceptable. Regular scans and blood tests will be conducted to monitor the treatment's effects.

Description

The main goals of this study are to find the safest dose of tegavivint and to see if it can help shrink tumors in children and young adults with certain types of cancer. The study will also look at any side effects and how the drug moves through the body. Participants will receive tegavivint through an IV infusion once a week for three weeks, followed by a week off, in a 28-day cycle. This treatment can continue for up to 26 cycles or 24 months unless the cancer worsens or side effects become too severe. Patients will have regular x-rays and scans to check the progress of the treatment. Blood samples will also be collected throughout the trial to help researchers understand how the drug is working. After finishing the treatment, patients will have follow-up visits every few months for several years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Age between 12 months and 21 years for Part A, and between 12 months and 30 years for Part B.
  • Have solid tumors that have returned or are not responding to treatment, including lymphomas and desmoid tumors.
  • Must have had a confirmed diagnosis of cancer at the start or relapse.
  • For Part A, patients must have either measurable or evaluable disease.
  • For Part B, patients must have measurable disease.
  • Must be in good overall health with a performance status score of 0, 1, or 2.
  • Must have recovered from any side effects of previous cancer treatments.
  • Must meet specific blood count and organ function criteria.
  • Must not have received tegavivint before.
  • Must agree to use effective birth control methods if of reproductive potential.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.
  • Cannot be taking corticosteroids unless on a stable or decreasing dose for at least 7 days before joining the study.
  • Cannot be taking other investigational drugs or anti-cancer agents.
  • Cannot be taking drugs to prevent graft-versus-host disease after a bone marrow transplant.
  • Cannot be taking drugs that strongly affect the liver enzyme CYP3A4.
  • Cannot have received bisphosphonates or denosumab within a certain period before the study.
  • Cannot have primary brain tumors or known brain metastases, except for craniopharyngeal tumors.
  • Cannot have certain bone diseases or disorders affecting bone metabolism.
  • Cannot have uncontrolled infections or have had a solid organ transplant.
  • Must be able to comply with the study's safety monitoring requirements.

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