Phase II Study of Sacituzumab Tirumotecan With or Without Tislelizumab in Adults With Advanced Anaplastic, Poorly Differentiated, or Radioiodine-Refractory Differentiated Thyroid Cancer

What this Trial Is About

Researchers are evaluating sacituzumab tirumotecan with or without tislelizumab in patients with advanced forms of thyroid cancer, including unresectable, locally advanced, or metastatic anaplastic thyroid carcinoma ATC, poorly differentiated thyroid carcinoma PDTC, and radioactive iodine-refractory differentiated thyroid cancer RAIR-DTC. This exploratory Phase II study aims to assess the safety and effectiveness of these treatments, with a focus on overall survival in the ATC group and progression-free survival in the PDTC and RAIR-DTC groups. Patients with ATC will receive a combination of sacituzumab tirumotecan and tislelizumab administered intravenously every six weeks on specific days. Those with PDTC or RAIR-DTC will receive sacituzumab tirumotecan alone on the same schedule. The study is open-label and includes multiple cohorts based on cancer type, with treatment continuing up to approximately 24 months. Participants will be closely monitored through regular assessments including imaging to measure tumor response, survival status, and side effects. Researchers will track overall survival and progression-free survival as primary outcomes, along with response rates and safety events, up to two years following treatment initiation. The study involves ongoing safety follow-up and comprehensive data collection to understand the effects of these therapies in advanced thyroid cancer.

Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer