Phase I Study of 177Lu-CTR-FAPI Radioligand Therapy for Thyroid Cancer Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating 177Lu-CTR-FAPI, a new radiopharmaceutical, for treating thyroid cancer in a multi-center, open-label phase I trial. The study aims to determine the safety, tolerability, and preliminary effectiveness of this treatment, focusing on dose-limiting toxicities to find the maximum tolerated dose. The research also assesses biochemical and radiological responses, quality of life improvements, and the dosimetry profile of 177Lu-CTR-FAPI. Participants will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. The dosing starts at 100 mCi and increases by 50 mCi increments following a standard 33 dose-escalation design. Dose delays are allowed based on treatment response or recovery needs, with a maximum delay of 12 weeks after the previous dose. Vital signs and adverse reactions will be closely monitored during infusions. During the study, participants will undergo assessments including biochemical and radiological evaluations, quality of life and pain score measurements, and dosimetry scans to measure radiation absorbed by organs and tumors. The primary outcome focuses on safety and dose-limiting toxicities within 6 weeks after the first injection. Secondary outcomes include response rates, survival, and quality of life changes up to one year after the last treatment. Overall, the trial involves close monitoring and evaluation over several months to understand the treatments safety and impact.

177Lu-CTR-FAPI for the Treatment of Thyroid Cancer