Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer
A Multicenter, Multi-Cohort, Phase II Study of Sacituzumab Tirumotecan With or Without Tislelizumab in Patients With Advanced Thyroid Cancer
Zhejiang Provincial People's Hospital
94 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
Summary
This is a multicenter, open-label, multi-cohort Phase II exploratory study designed to evaluate the efficacy and safety of sacituzumab tirumotecan with or without tislelizumab in patients with unresectable, locally advanced, or metastatic anaplastic thyroid carcinoma (ATC), poorly differentiated thyroid carcinoma (PDTC), or radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC). Patients with ATC will receive sacituzumab tirumotecan in combination with tislelizumab. Patients with PDTC and RAIR-DTC will receive sacituzumab tirumotecan monotherapy. The primary objective in the ATC cohort is overall survival (OS). In the PDTC and RAIR-DTC cohorts, the primary objective is progression-free survival (PFS) assessed by investigators per RECIST v1.1.
Eligibility
Plain Language Summary
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Interventions
Sacituzumab tirumotecan: 5mg/kg, IV, Q6W, D1, D15, D29 Tislelizumab: 200mg, IV, Q6W, D1, D15, D29
Sacituzumab tirumotecan: 5mg, IV, Q6W, D1, D15, D29
Locations(1)
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NCT07068542