A Single-Center, Single-Arm, Open-Label Clinical Study of 177Lu-CTR-FAPI Injection in the Treatment of Patients With Advanced, Metastatic Solid Tumors
This is a single-center, single-arm, open-label clinical study of 177Lu-CTR-FAPI injection in the treatment of patients with advanced, metastatic solid tumors i.e. pancreatic cancer, to assess safety, radio-dosimetry, and efficacy per RESIST 1.1.
• 1: Patients with unresectable, advanced, or metastatic solid tumors who have been histologically or cytologically confirmed, have failed standard treatment, lack standard treatment options, or refuse standard treatment. Preferred tumor types include pancreatic cancer, breast cancer, and soft tissue sarcoma, and must meet any of the following tumor-specific criteria:
‣ Patients with advanced or metastatic TNBC who have progressed after or are intolerant to at least 2 lines of systemic therapy;
⁃ Patients with HER2-positive advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of HER2-targeted therapy;
⁃ Patients with HR/HER2-negative advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of systemic therapy;
⁃ Patients with advanced or metastatic high-grade soft tissue sarcoma (excluding chordoma) who have progressed after or are intolerant to at least 1 line of systemic therapy;
⁃ Patients with advanced or metastatic pancreatic cancer who have progressed after or are intolerant to at least 1 line of systemic therapy.
• 2: Age \>= 18 years, regardless of sex;
• 3: Able to understand and sign informed consent and willing and able to comply with study and follow-up procedures;
• 4: ECOG performance status score of 0 or 1;
• 5: FAP expression in tumor lesions confirmed positive by FAPI PET/CT;
• 6: Agree to provide archived or fresh tumor tissue for immunohistochemical evaluation (if available);
• 7: At least 1 measurable lesion according to RECIST 1.1 criteria;
• 8: Previous anti-tumor toxicities recovered to grade 0-1;
• 9: Organ function meets requirements before first administration;
‣ Hematology: Absolute neutrophil count (ANC) \>= 1.5×10\^9/L; Hemoglobin (Hb) \>= 80 g/L; Platelet count (PLT) \>= 75×10\^9/L;
⁃ Liver function: Total bilirubin (TB) \<= 1.5×ULN; AST and ALT \<= 3×ULN, and if there is hepatic tumor metastasis, ALT and AST \<= 5×ULN;
⁃ Renal function: Creatinine clearance \>= 50 mL/min (Cockcroft-Gault formula); ECG: QTcF \<= 470 ms;
• 10: Fertile subjects voluntarily use effective contraception during treatment and for 4 months (male) or 7 months (female) after the last dose of study drug.