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OncoMatch/Clinical Trials/NCT06235216

Sacituzumab govitEcan in THYroid Cancers

Is NCT06235216 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab govitecan for differentiated thyroid cancer.

Phase 2RecruitingGrupo Espanol de Tumores NeuroendocrinosNCT06235216Data as of May 2026

Treatment: Sacituzumab govitecanSETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC). The main hypothesis is that treatment with sacituzumab govitecan, a anti-Trophoblast cell surface antigen 2 (TROP-2), could be an effective treatment option for patients with either differentiated and anaplastic thyroid neoplasms because TROP-2 is highly expressed at the membrane of DTC and ATC.

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Extracted eligibility criteria

Cancer type

Thyroid Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: systemic therapy (sorafenib, lenvatinib, cabozantinib) — differentiated thyroid cancer (cohort A)

Cohort A: Patients must have experienced progression on at least one previous treatment line with approved systemic therapies (Sorafenib, Lenvatinib or Cabozantinib) and a maximum of 3 prior systemic therapies.

Cannot have received: topoisomerase 1 inhibitor

Patient has previously received topoisomerase 1 inhibitors.

Lab requirements

Blood counts

Neutrophil count (ANC) ≥ 1,500/mm3; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL

Kidney function

Creatinine clearance (CrCl) ≥ 60 mL/min as estimated by the Cockroft-Gault formula or as measured by 24 hour urine collection (GFR can also be used instead of CrCl)

Liver function

Serum bilirubin ≤ 1.5 × ULN (patients with Gilbert's disease are excluded); ALT and AST ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases; serum albumin > 3 g/dL

Cardiac function

No myocardial infarction or unstable angina pectoris within 6 months; no history of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for well-controlled atrial fibrillation); no history of QT interval prolongation; NYHA class III or greater congestive heart failure or LVEF < 40% excluded

The following baseline laboratory data without transfusional support: Neutrophil count (ANC) ≥ 1,500/mm3. Platelet count ≥ 100 × 10^9/L. Hemoglobin ≥ 9 g/dL. Serum bilirubin ≤ 1.5 × ULN. Serum albumin > 3 g/dL. Creatinine clearance (CrCl) ≥ 60 mL/min. ALT and AST ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases. Cardiac exclusion criteria: see exclusion 6.

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

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