FAP-positive advanced gastrointestinal malignancy
Conditions
Interventions
Group 177Lu-LNC1004:Receive treatment with 177Lu-LNC1004 injection, intravenous injection of 80 mCi (2.96 GBq) each time, once every 6 weeks, for a total of no more than 6 times
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Have a willingness to communicate with the investigator, be able to understand and follow the requirements of the trial, voluntarily participate in the trial, understand and sign the written informed consent; 2. Age>=18 years old, gender is not limited; 3. Expected survival of at least 3 months; 4. The performance status of the Eastern Cooperative Oncology Group (ECOG) score is 0~2; 5. Patients with advanced gastrointestinal malignancies confirmed by histology or cytology who have failed standard treatment or lack of standard treatment or refused standard treatment; 6. At least one measurable target lesion according to RECIST 1.1 criteria; 7. Confirmed to be FAP positive by 18F/68Ga-FAPI PET scan; 8. Have adequate organ function: - Bone marrow reserve: neutrophil count >=1.5×10^9/L; Platelet count>=90×10^9/L; hemoglobin >=90 g/L; - Liver function: AST/ALT 2.8 g/dL; Total bilirubin =50 mL/min (according to Cockcroft-Gault formula); 9. Subjects have recovered from toxic reactions caused by previous treatment (<=grade 1 or baseline before treatment), except for alopecia, vitiligo, etc.; 10. For male or female subjects of childbearing potential: agree to abstain from sexual intercourse or use effective contraceptive methods, including intrauterine devices, for at least 24 weeks from the beginning of signing the ICF until the last dose of 177Lu-LNC1004 injection; 11. Agree to take radiation protection measures according to the doctor's instructions during the test.
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant or lactating, or have a positive baseline blood pregnancy test test; 2. Those who have had severe allergic reactions to 177Lu-LNC1004 injection and 18F/68Ga components in the past; 3. Received blood transfusion therapy within 4 weeks before screening to make the subjects meet the enrollment criteria; 4. Received any investigational drug within 28 days before the first dose, or participated in another clinical study at the same time (except for the subject who participated in an observational or non-interventional clinical study, or was in the follow-up period of an interventional clinical study); 5. Received systemic anti-cancer therapy, such as radiotherapy, chemotherapy, immunotherapy, or biological therapy, within 4 weeks before the first dose; or planned use of cytotoxic chemotherapy drugs, anti-tumor immunotherapy, radioligand therapy, or other similar anti-tumor drugs during the trial; 6. History of other known malignant tumors within the past 5 years, except for cured localized tumors, including carcinoma in situ of the cervix, basal cell carcinoma of the skin and carcinoma in situ of the prostate, etc.; 7. Primary central nervous system (CNS) malignant tumor; Subjects with CNS metastases who have failed local therapy; Subjects with asymptomatic brain metastases within 28 days prior to enrollment, or who are clinically stable and do not require steroids and other treatments for brain metastases, can be enrolled; 8. Those who are positive for hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIV), and syphilis antibody at screening; 9. Patients who are positive for hepatitis B surface antigen (HBsAg) at screening also need to be tested for hepatitis B virus deoxyribonucleic acid (HBV-DNA), and those who are judged by the investigator to be in the viral active replication period cannot be included; 10. Patients who need immunosuppressive therapy for allogeneic organ transplantation; 11. Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy; 12. Have serious cardiovascular clinical diseases or symptoms that may increase the safety risk of the subject, including: - Congestive heart failure (New York Heart Association [NYHA] class > II.) within the previous 1 year; - Unstable angina pectoris within the past 1 year; - Myocardial infarction within the previous 1 year; - Clinically significant malignant arrhythmias (except atrial fibrillation, paroxysmal supraventricular tachycardia); - presence of clinically significant QTcF prolongation (QTcF >470 ms, calculated by Fridericia's formula); 13. Clinically significant bleeding (such as gastrointestinal bleeding, intracranial hemorrhage) within 14 days before the first dose; 14. Received major surgery or severe trauma within 28 days before the first medication; 15. Severe urinary incontinence, voiding dysfunction or urinary tract obstruction; 16. Those who are unable to undergo PET/CT scan due to weight restriction or other reasons; 17. There are other conditions that, in the opinion of the investigator, may increase the safety risk or interfere with its interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;Focus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemistry;Urine routines;Electrocardiograph; | — |
Countries
China
Contacts
Public ContactSong shaoli
Fudan University Shanghai Cancer Center
Outcome results
None listed