Actively Recruiting
Study of Tegavivint, a Transducin Beta-like Protein 1 (TBL1) Inhibitor, With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
Led by Emory University · Updated on 2026-06-02
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
I
Iterion Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the maximum tolerated dose and recommended phase 2 dose of Tegavivint combined with Gemcitabine in patients who have relapsed or refractory osteosarcoma, a bone cancer with poor survival after relapse. This study focuses on understanding the side effects and toxicities of this drug combination in this patient group, aiming to find new treatment options where current chemotherapy agents have limited success, especially for unresectable disease. Participants receive treatment cycles lasting 21 days, up to 17 cycles or about 12 months. Gemcitabine is given intravenously over 60 minutes on days 1 and 8 at a fixed dose, followed by Tegavivint administered intravenously over 4 hours on days 1, 8, and 15 at escalating dose levels starting from 3 mg/kg up to 6.5 mg/kg. Treatment stops if the disease progresses or if side effects require discontinuation. Throughout the study, participants will undergo regular assessments for disease status, side effects, and overall health, including performance scores and organ function tests. Researchers will monitor tumor response and control, progression-free survival, and overall survival over time. The primary measurement is the highest dose tolerated by patients up to day 21 of treatment. This trial is expected to continue until May 2028, with ongoing evaluations to guide future therapy development.
CONDITIONS
Brief Title
Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic confirmation of osteosarcoma at diagnosis or relapse
- Relapsed or refractory osteosarcoma with prior front-line treatment containing at least three of these: methotrexate, doxorubicin, cisplatin, and ifosfamide
- Measurable or evaluable disease per RECIST during dose escalation; measurable, evaluable, or no evidence of disease after pulmonary metastasectomy during dose expansion
- Lansky or Karnofsky performance score of 60 or higher, or ECOG score of 2 or less
- Fully recovered from acute effects of prior chemotherapy, immunotherapy, surgery, or radiation as specified (varies by treatment type)
- Adequate bone marrow, renal, liver, pulmonary, and cardiac function as defined
- Agreement to take vitamin D and calcium supplements if needed
- Age between 1 and 30 years
You will not qualify if you...
- History of intraparenchymal CNS osteosarcoma unless stable for 3 months
- Pregnancy or breastfeeding
- Childbearing potential without negative pregnancy test or without agreed contraception methods
- Currently receiving other investigational or anti-cancer drugs
- Use of strong CYP3A4 inducers or inhibitors within 14 days before treatment
- Bisphosphonate use within 4 weeks or denosumab within 180 days before enrollment
- Active, uncontrolled infection
- Prior solid organ or allogeneic stem cell transplantation
- Inability to comply with safety monitoring
- Known metabolic bone diseases or disorders affecting bone metabolism
- Grade 2 or higher hypocalcemia not corrected by oral supplements
- Vitamin D levels below 20 ng/mL without supplementation
- Previous treatment with Tegavivint
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 17 cycles (approximately 12 months)
Participants receive treatment with tegavivint and gemcitabine in repeated 21-day cycles. Gemcitabine is given intravenously on days 1 and 8, followed by tegavivint administered intravenously on days 1, 8, and 15. Treatment may continue for up to 17 cycles, approximately 12 months, unless disease progression or unacceptable toxicity occurs.
Multiple visits per 21-day cycle corresponding to drug administration days
Trial Site Locations
Total: 1 location
1
Arthur M. Blank Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
K
Kate Glasscox, BSN, RN
M
Melissa Schink
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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