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OncoMatch/Clinical Trials/NCT06959641

XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer

Is NCT06959641 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zanzalintinib for locally advanced differentiated thyroid gland carcinoma.

Phase 2RecruitingNorthwestern UniversityNCT06959641Data as of May 2026

Treatment: ZanzalintinibThis phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment with radioiodine (radioiodine refractory) and that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). XL092 is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing.

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Extracted eligibility criteria

Disease stage

Required: Stage III, IV, STAGE III, STAGE IV (AJCC v8)

locally advanced or metastatic, radioactive iodine (RAI) refractory, differentiated thyroid cancer...measurable disease according to RECIST v 1.1

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: XL092 (zanzalintinib) (XL092)

Prior treatment with XL092 (zanzalintinib)

Cannot have received: small molecule kinase inhibitor

Receipt of any type of small molecule kinase inhibitor treatment (including investigational kinase inhibitor) within 2 weeks before the first dose of study treatment

Cannot have received: cytotoxic, biologic, or other systemic anticancer therapy

Exception: nitrosoureas or mitomycin C < 6 weeks prior to planned treatment start date

Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational therapy or investigational device) within 4 weeks before the first dose of study treatment

Cannot have received: radiation therapy for bone metastases

Radiation therapy for bone metastases within 2 weeks before the first dose of study treatment

Cannot have received: other radiation therapy

any other radiation therapy within 4 weeks before the first dose of study treatment

Cannot have received: systemic treatment with radionuclides

Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment

Lab requirements

Blood counts

Leukocytes (WBC) ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Hemoglobin ≥ 9 g/dL; Platelets ≥ 100,000/mcL

Kidney function

Creatinine Clearance (CrCl) ≥ 40 mL/min (≥ 0.67 mL/sec) using Cockcroft-Gault equation

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 for bone metastasis)

Cardiac function

QTcF ≤ 480 ms within 14 days per ECG before first dose

Leukocytes (WBC) ≥ 3,000/mcL; ANC ≥ 1,500/mcL; Hemoglobin (Hgb) ≥ 9 g/dL; Platelets (PLT) ≥ 100,000/mcL; Total bilirubin ≤ 1.5 x ULN; AST ≤ 3 x ULN; ALT ≤ 3 x ULN; ALP ≤ 3 x ULN; CrCl ≥ 40 mL/min; QTcF ≤ 480 ms

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

US trial sites

  • Northwestern University · Chicago, Illinois

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