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

Summary

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.

Conditions

• Colorectal Carcinoma
• Endometrial Carcinoma
• Melanoma
• Neuroblastoma
• Ovarian Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Recurrent Desmoid Fibromatosis
• Recurrent Ewing Sarcoma
• Recurrent Hepatoblastoma
• Recurrent Hepatocellular Carcinoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Non-Hodgkin Lymphoma
• Recurrent Osteosarcoma
• Refractory Desmoid Fibromatosis
• Refractory Ewing Sarcoma
• Refractory Hepatoblastoma
• Refractory Hepatocellular Carcinoma
• Refractory Malignant Solid Neoplasm
• Refractory Non-Hodgkin Lymphoma
• Refractory Osteosarcoma
• Solid Pseudopapillary Neoplasm of the Pancreas
• Wilms Tumor

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Dual X-ray Absorptiometry

Undergo DEXA scan

DRUG

Tegavivint

Given IV

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Sarah B Whittle · Pediatric Early Phase Clinical Trial Network

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-08

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations