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OncoMatch/Clinical Trials/NCT06571734

XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma

Is NCT06571734 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zanzalintinib for metastatic leiomyosarcoma.

Phase 2RecruitingNorthwestern UniversityNCT06571734Data as of May 2026

Treatment: ZanzalintinibThis 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Disease stage

Metastatic disease required

metastatic or unresectable; measurable disease according to RECIST v1.1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: antineoplastic treatment

Patients must have undergone 1 prior line of antineoplastic treatment

Cannot have received: XL092 (XL092)

Patients who have received previous treatment with XL092

Cannot have received: small-molecule kinase inhibitor

Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study day 1 treatment

Cannot have received: tyrosine kinase inhibitor

Patients who have received > 2 prior tyrosine kinase inhibitor therapies

Cannot have received: chemotherapy

Exception: unless completed > 4 weeks prior to study day 1 and recovered from toxicity/complications

Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to study day 1 unless they have recovered from their prior therapy (toxicity and/or complications) such that they now meet all other eligibility criteria

Cannot have received: radiation therapy

Exception: unless completed > 4 weeks prior to study day 1 and recovered from toxicity/complications; for bone metastasis, radiation therapy within 14 days prior to registration is excluded

Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to study day 1 unless they have recovered from their prior therapy (toxicity and/or complications) such that they now meet all other eligibility criteria; Patients who have received radiation therapy for bone metastasis within 14 days prior to registration

Cannot have received: radionuclide therapy

Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment

Cannot have received: investigational agent

currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of treatment

Lab requirements

Blood counts

WBC ≥ 3,000/mcL; ANC ≥ 1,500/mcL (without G-CSF support within 14 days); Hgb ≥ 9 g/dL without transfusion within 14 days; Platelets ≥ 100,000/mm^3 without transfusion within 14 days; INR ≤ 1.5; aPTT ≤ 1.2 x ULN

Kidney function

Serum creatinine ≤ 1.5 x 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 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

Leukocytes (white blood cells [WBC]) ≥ 3,000/mcL ... ejection fraction > 50% by either MUGA scan or echocardiogram ... Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Northwestern University · Chicago, Illinois

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