Actively Recruiting
Phase 2
Age: 18Years +
All Genders
NCT07193550
A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
70
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and/or metastatic bone sarcomas.
CONDITIONS
Official Title
A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older with confirmed unresectable locally advanced or metastatic bone sarcoma in one of these groups: osteosarcoma, Ewing sarcoma, conventional chondrosarcoma (grades 2-3), or other primary bone sarcomas
- Patients with conventional chondrosarcoma must show disease progression by RECIST 1.1 within 12 weeks before enrollment
- Patients must have relapsed or be refractory to conventional therapy with at least one prior systemic therapy line unless no standard treatment exists
- No more than two prior lines of systemic therapy for advanced/metastatic disease are allowed
- Multi-agent or alternating neoadjuvant/adjuvant chemotherapy counts as one line of systemic therapy if given for metastatic disease
- ECOG performance status 0, 1, or 2 (Karnofsky score 60% or higher)
- Weight at least 40 kg
- Measurable disease per RECIST 1.1
- Prior radiation allowed if measurable disease per RECIST 1.1 and at least 21 days since completion
- Adequate blood counts: ANC ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin >9 g/dL
- INR ≤1.5 and aPTT <1.2 times upper normal limit except for those on anticoagulation
- Renal function: creatinine clearance ≥40 mL/min
- Hepatic function: AST and ALT <3 times upper normal limit, total bilirubin ≤1.5 times upper normal limit (up to 3 times for Gilbert's disease), serum albumin ≥2
- Agree to consent and co-enroll on MD Anderson MOSAIC protocol for sample collection
- Undetectable HBV viral load if chronic hepatitis B infection
- HCV infection treated and cured, or undetectable viral load if on treatment
- Treated brain metastases allowed if no progression on follow-up imaging
- Prior malignancy allowed if not interfering with safety or efficacy assessment
- Cardiac function New York Heart Association class 2B or better
- Female subjects of childbearing potential must not be pregnant and agree to use effective contraception; men must agree to avoid sperm donation for 96 days after last dose; women must avoid egg donation for 186 days after last dose
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Prior treatment with zanzalintinib
- Primary soft tissue sarcoma with bone metastasis
- Known allergy or hypersensitivity to study agents
- Prior treatment with other VEGF-targeted tyrosine kinase inhibitors
- Use of any small molecule kinase inhibitor within 2 weeks before study treatment
- Untreated central nervous system metastases, leptomeningeal disease, or spinal cord compression
- Active infection requiring intravenous antibiotics within 2 weeks
- Receipt of investigational drug or procedure within 21 days before study day 1
- Anti-tumor therapy within 21 days before study day 1
- Radiation therapy for bone metastasis within 2 weeks or other radiation therapy within 4 weeks prior to treatment
- Use of complementary medicine for bone sarcoma within 2 weeks before treatment
- History of significant cardiac disease, uncontrolled hypertension, or moderate to severe liver impairment
- Detectable HIV viral load or known acute/chronic hepatitis B or C infection
- History of solid organ or allogeneic stem cell transplant
- Other malignancy within 2 years prior to treatment except those in remission without recent treatment
- Recent stroke, myocardial infarction, thromboembolic events, or venous events within specified timeframes
- Gastrointestinal disorders with risk of perforation or fistula, active infections, or recent complications
- Significant bleeding events within 12 weeks before treatment
- Symptomatic cavitating pulmonary lesions or lesions invading major blood vessels
- Serious non-healing wounds, malabsorption syndromes, uncompensated hypothyroidism, or dialysis requirement
- Major surgery within 8 weeks or minor surgery within 5 days before treatment without complete healing
- Corrected QT interval >470 ms on ECG within 14 days before treatment
- Psychiatric or social conditions limiting study compliance
- Pregnant or lactating women
- Inability to swallow tablets or ingest medication by tube
- Use of certain oral anticoagulants; only specified anticoagulants allowed
- Proteinuria greater than 1 gram per day
- Any other condition that may compromise patient safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
J
John Livingston, MD
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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