Actively Recruiting
A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With 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
N/A
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
Researchers are evaluating tegavivint, a drug that blocks signals inside cells that tell tumors to grow, in children, adolescents, and young adults with solid tumors that have returned or do not respond to treatment. This phase I/II trial aims to find the highest safe dose, assess side effects, and explore possible benefits for various cancers including lymphomas, desmoid tumors, Ewing sarcoma, liver tumors, osteosarcoma, and Wilms tumor. The study also examines how the drug affects tumor biology and blood markers related to the WNT/beta-catenin pathway. Participants receive tegavivint through an intravenous infusion lasting 4 hours on days 1, 8, and 15 of each 28-day cycle. Treatment can continue for up to 26 cycles or 24 months if the disease does not worsen or side effects are tolerable. Doses start at 5 mg/kg and may increase or decrease depending on patient response. Patients undergo imaging tests including x-rays and dual x-ray absorptiometry (DEXA) scans at scheduled intervals to monitor tumor status and bone health. During the study, patients have regular assessments such as blood sample collections and imaging scans before and during treatment. Follow-up visits occur every 3 months for a year, then every 6 months for two years, and annually up to five years after treatment ends. Researchers measure side effects, drug levels in the body, and tumor response to understand tegavivint's safety and potential effects. Patients are closely monitored for safety throughout this period.
CONDITIONS
Brief 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 non-Hodgkin lymphoma and desmoid tumors
- Patients in Part B must have recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, or tumors with Wnt pathway abnormalities
- Patients must have measurable or evaluable disease; desmoid tumors must be unresectable or morbid enough to justify trial participation
- Performance status must be ECOG 0, 1, or 2 using Karnofsky (over 16 years) or Lansky (16 years or younger) scales
- Patients must have recovered from prior cancer treatments with specified waiting periods depending on therapy type
- No prior exposure to tegavivint
- Adequate blood counts including ANC ≥ 1000/uL, platelets ≥ 100,000/uL, hemoglobin ≥ 8.0 g/dL
- Adequate kidney function with creatinine clearance or GFR ≥ 70 mL/min/1.73 m2 or age/gender-based creatinine limits
- Liver function within specified normal limits including bilirubin ≤ 1.5 x ULN and ALT ≤ 135 U/L
- Albumin ≥ 2 g/dL
You will not qualify if you...
- Pregnant or breastfeeding women; pregnancy tests required for post-menarchal girls
- Patients not on stable or decreasing corticosteroid doses for at least 7 days prior to enrollment
- Currently receiving other investigational or anti-cancer drugs
- Using cyclosporine, tacrolimus, or similar drugs to prevent graft-versus-host disease after bone marrow transplant
- Taking strong CYP3A4 inducers or inhibitors from 14 days before first tegavivint dose through study end
- Received bisphosphonates within 4 weeks or denosumab within 180 days before enrollment
- Primary brain tumors or known central nervous system metastases (except craniopharyngeal tumors)
- Known metabolic bone diseases or disorders affecting bone metabolism
- Grade 2 or higher hypocalcemia not corrected with oral calcium
- Vitamin D levels below 20 ng/mL without supplementation
- Pre-existing grade 3 osteoporosis
- Uncontrolled infections
- Prior solid organ transplantation
- Unable to comply with study safety monitoring requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive tegavivint as an intravenous infusion over 4 hours on days 1, 8, and 15 of each 28-day cycle. Treatment repeats for up to 26 cycles or 24 months unless disease progression or unacceptable toxicity occurs. Participants undergo x-rays and DEXA scans at scheduled intervals during treatment, and blood samples may be collected throughout the trial.
Weekly visits on days 1, 8, and 15 of each 28-day cycle
Duration - Up to 60 months
After completing treatment, participants are followed up every 3 months for 12 months, then every 6 months for 24 months, and annually up to 60 months to monitor health and any long-term effects.
Visits every 3 months for 12 months, then every 6 months for 24 months, then annually
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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