Clinical Trial to Evaluate the Antitumor Efficacy and Safety of 177Lu-LNC1004 Injection in Patients With Fibroblast Activating Protein (FAP)-Positive Radioiodine-refractory Differentiated Thyroid Cancer (RAIR-DTC) Who Have Failed TKIs Treatment or Refuse Standard Treatment
177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.
• Subject must have the ability to understand and sign an approved informed consent form (ICF).
• Aged 18 years or older, regardless of sex.
• Histologically or cytologically confirmed RAIR-DTC subject who has failed TKIs treatment or refuse standard therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• At least one measurable lesion as defined by Response Criteria in Solid Tumors (RECIST) version 1.1.
• Life expectancy of at least 6 months.
• FAP-positive lesion confirmed by FAPI PET/CT scan.
• Adequate organ function as defined by：
‣ Bone marrow function: hemoglobin ≥ 100 g/L, neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L;
⁃ Liver function: albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 × ULN; ALT and AST \< 3 × ULN without liver metastasis or \< 5 × ULN with liver metastasis;
⁃ Renal function: creatinine clearance ≥ 60 mL/min.
• Clinically significant toxic reactions related to prior antitumor treatment that have recovered to Grade ≤ 1 (CTCAE V5.0).