Clinical Trial

Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-06; most recent amendment 2026-05-27.
Status change: Not Yet Recruiting → Recruiting 2026-02-21
Trial Details
NCT Number NCT07068542
Lead Sponsor Zhejiang Provincial People's Hospital
Conditions Advanced Thyroid Carcinoma, Radioiodine-refractory Differentiated Thyroid Cancer, Poorly Differentiated Thyroid Carcinoma
Enrollment 94 participants
Start Date 2025-07-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-01