Actively Recruiting
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
Led by Children's Oncology Group · Updated on 2026-05-05
147
Participants Needed
21
Research Sites
346 weeks
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be between 12 months and 21 years old for Part A, or between 12 months and 30 years old for Part B at enrollment
- Patients must have recurrent or refractory solid tumors, including non-Hodgkin lymphoma and desmoid tumors, confirmed by tissue diagnosis
- Patients in Part A must have relapsed or refractory solid tumors, including lymphoma and desmoid tumors
- Patients in Part B must have recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (hepatocellular carcinoma and hepatoblastoma), Wilms tumor, or tumors with Wnt pathway abnormalities
- Patients must have measurable or evaluable disease; for desmoid tumors, disease must be unresectable or cause significant risk or morbidity
- Patients must have ECOG performance status of 0, 1, or 2 (Karnofsky or Lansky scores used based on age)
- Patients must have recovered from prior cancer treatments and meet specific waiting periods depending on treatment type
- No prior exposure to tegavivint
- Patients with adequate blood counts and kidney and liver function as defined by specific lab values
- Patients with bone marrow involvement may participate if blood counts meet criteria
- Patients must agree to take vitamin D and calcium supplements if needed
You will not qualify if you...
- Pregnant or breastfeeding women are excluded; females of childbearing potential must have negative pregnancy test and agree to use two forms of birth control during the study
- Patients on corticosteroids must be on stable or decreasing doses for at least 7 days before enrollment
- Patients currently receiving other investigational drugs or anti-cancer agents are excluded
- Patients on drugs that strongly affect CYP3A4 enzyme are excluded
- Patients who received bisphosphonates within 4 weeks or denosumab within 180 days before enrollment are excluded
- Patients with primary brain tumors or known CNS metastases (except craniopharyngeal tumors) are excluded
- Patients with metabolic bone diseases or disorders affecting bone metabolism are excluded
- Patients with uncorrected grade 2 or higher low calcium levels are excluded
- Patients with vitamin D levels below 20 ng/mL must receive supplements or are excluded
- Patients with severe osteoporosis (grade 3) are excluded
- Patients with uncontrolled infections or prior solid organ transplants are excluded
- Patients unable to comply with study safety monitoring are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
4
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States, 94304
Active, Not Recruiting
5
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
6
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
7
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
8
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
9
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
11
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
14
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
15
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
16
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
17
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
18
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
19
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
20
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
21
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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