Actively Recruiting
Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
Led by Emory University · Updated on 2026-03-02
24
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
I
Iterion Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to define the maximum tolerated dose (MTD) and/or Recommended phase 2 dose (RP2D) of Tegavivint in combination with Gemcitabine in patients with relapsed or refractory osteosarcoma (OS). The study will also investigate the toxicities of Tegavivint in combination with gemcitabine in patients with relapsed or refractory OS.
CONDITIONS
Official 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 original diagnosis or relapse
- Relapsed or refractory osteosarcoma with prior front-line treatment including at least three of methotrexate, doxorubicin, cisplatin, and ifosfamide
- Dose escalation phase: measurable or evaluable disease per RECIST; dose expansion phase: includes patients with no evidence of disease after pulmonary metastasectomy
- Performance status of Lansky score 60 if 16 years or younger, Karnofsky score 60 if older than 16 years, or ECOG score 2
- Full recovery from acute effects of prior chemotherapy, immunotherapy, surgery, or radiation according to specified timelines
- Adequate bone marrow function: ANC 6 750/mm3, platelets 6 75,000/mm3
- Adequate kidney function: creatinine clearance or GFR 6 70 ml/min/1.73 m2
- Adequate liver function: bilirubin 6 1.5 times upper limit of normal, ALT 6 5 times upper limit of normal
- Adequate lung function: no dyspnea at rest, no exercise intolerance, oxygen saturation >93% on room air
- Adequate heart function: QTc 6 470 ms by Fridericia formula
You will not qualify if you...
- History of intraparenchymal CNS disease unless stable for at least 3 months
- Pregnancy or breastfeeding
- Female patients of childbearing potential without a negative pregnancy test
- Patients of reproductive potential not agreeing to use two effective birth control methods
- Currently receiving other investigational or anti-cancer drugs
- Currently taking strong CYP3A4 inducers or inhibitors, bisphosphonates within 4 weeks, or denosumab within 180 days
- Active, uncontrolled infection
- Prior solid organ or allogeneic stem cell transplant
- Inability to comply with study safety monitoring
- Known metabolic bone diseases or disorders affecting bone metabolism
- Grade 2 or higher hypocalcemia not corrected by oral calcium
- Vitamin D level below 20 ng/mL without supplementation
- Previous treatment with tegavivint
AI-Screening
AI-Powered Screening
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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
CONTACT
L
Lauren Johnson
CONTACT
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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