Phase II Study of Sacituzumab Govitecan for Advanced or Metastatic Differentiated and Anaplastic Thyroid Cancer

What this Trial Is About

Researchers are evaluating sacituzumab govitecan as a treatment option for patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma DTC or anaplastic thyroid carcinoma ATC. This phase II, single-arm, non-randomized study aims to assess the effectiveness and safety of sacituzumab govitecan, which targets TROP-2, a protein highly expressed in these thyroid cancers. The study will include patients who have progressed after prior treatments or are in first-line settings for ATC. Participants will receive sacituzumab govitecan at a dose of 10 mgkg given intravenously on Days 1 and 8 of a 21-day treatment cycle. Treatment will continue until disease progression, death, unacceptable toxicity, or withdrawal from the study. The study consists of two cohorts one with patients having advanced DTC who have progressed after previous tyrosine kinase inhibitors, and another with patients having advanced or metastatic ATC receiving first-line or subsequent treatments. Dosing adjustments may be made based on patient weight and tolerability. During the study, patients will undergo tumor assessments using CT or MRI scans and blood tests for tumor markers every 12 weeks until disease progression or withdrawal. Researchers will measure outcomes such as objective response rate, disease control, duration of response, progression-free survival, overall survival, safety, and quality of life over approximately 42 months. The study design includes careful monitoring of treatment effects and patient well-being throughout participation.

Sacituzumab govitEcan in THYroid Cancers