OncoMatch/Clinical Trials/NCT06571734
XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma
Is NCT06571734 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Zanzalintinib for metastatic leiomyosarcoma.
Treatment: Zanzalintinib — This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma. The trial has now been expanded to treat additional sarcoma types that are sensitive to tyrosine kinase inhibitors (TKIs) such as translocation-associated soft tissue sarcoma (such as synovial sarcoma), and bone sarcoma (including osteosarcoma and Ewing sarcoma).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Sarcoma
Osteosarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Prior therapy
Must have received: antineoplastic treatment — leiomyosarcoma
Patients must have undergone at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).
Must have received: antineoplastic treatment — bone sarcoma
Patients must have undergone at least 1 line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).
Must have received: antineoplastic treatment — translocation-associated soft tissue sarcoma
Patients must have undergone greater than 2 lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI).
Cannot have received: XL092 (XL092)
Patients who have received previous treatment with XL092.
Cannot have received: tyrosine kinase inhibitor
Exception: no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI)
Patients who have received > 2 prior tyrosine kinase inhibitor therapies as anticancer treatments.
Lab requirements
Blood counts
ANC ≥ 1,500/mcL (without G-CSF support within 21 days); Hgb ≥ 9 g/dL without transfusion within 21 days; Platelets ≥ 100,000/mm^3 without transfusion within 21 days; INR ≤ 1.5 ULN; aPTT ≤ 1.2 x ULN
Kidney function
Serum creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 40 mL/min; Creatinine clearance ≥ 40 mL/min; Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.12 mg/mmol)
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (≤ 3 x ULN for Gilbert's disease); AST ≤ 3 x ULN; ALT ≤ 3 x ULN; ALP ≤ 3 x ULN (≤ 5 x ULN with bone metastasis)
Cardiac function
Ejection fraction > 50% by MUGA or echocardiogram; QTcF ≤ 480 ms within 14 days per ECG (average of 3 consecutive results)
See inclusion criteria for full organ function requirements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06571734 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior XL092, tyrosine kinase inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages