OncoMatch/Clinical Trials/NCT07193550
A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)
Is NCT07193550 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zanzalintinib for bone sarcomas.
Treatment: Zanzalintinib — To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and/or metastatic bone sarcomas.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — advanced/metastatic
Patients must have relapsed or become refractory to conventional therapy, receiving at least 1 prior line of systemic therapy unless no standard of care exists.
Cannot have received: zanzalintinib (zanzalintinib)
Prior treatment with zanzalintinib.
Cannot have received: VEGF-targeted TKI (cabozantinib, regorafenib, pazopanib)
Patients previously treated with other VEGF-targeted TKIs (including but not limited to cabozantinib, regorafenib, pazopanib, or similar).
Cannot have received: small molecule kinase inhibitor
Receipt of any small molecule kinase inhibitor (including investigational) within 2 weeks before first dose of study treatment.
Cannot have received: investigational study drug and/or procedure
Prior receipt of an investigational study drug and/or procedure within 21 days of study day 1.
Cannot have received: anti-tumor therapy
Anti-tumor therapy within 21 days of study day 1 including chemotherapy, antibody therapy, or other investigational agent.
Cannot have received: radiation therapy for bone metastasis
Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment
Lab requirements
Blood counts
ANC ≥ 1500/mm3 (growth factor/G-CSF permitted); Platelet count ≥ 100,000/mm3; Hemoglobin > 9 g/dL
Kidney function
calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft Gault equation
Liver function
AST and ALT < 3 x ULN and total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN), serum albumin ≥ 2
Cardiac function
NYHA class 2B or better; QTcF ≤ 470 ms within 14 days per ECG before first dose of study treatment
Hematological function, as follows: Absolute neutrophil count (ANC) ≥ 1500/mm3 (growth factor/G-CSF permitted); Platelet count ≥ 100,000/mm3; Hemoglobin > 9 g/dL. INR ≤ 1.5 and activated partial thromboplastin time (aPTT) < 1.2 x upper limit of normal (ULN), except subjects on anticoagulation. Renal function as follows: calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft Gault equation. Hepatic function as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN and total bilirubin ≤ 1.5 x ULN (for subjects with Gilberts's disease ≤ 3 x ULN), serum albumin ≥ 2. Cardiac: NYHA class 2B or better; QTcF ≤ 470 ms within 14 days per ECG before first dose of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
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