Late stage malignant solid tumor patients with protein (FAP) positivity
Conditions
Interventions
177Lu FAPI FUSCC treatment group:Receive treatment with 177Lu FAPI FUSCC 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: Inclusion Criteria 1) Willing to communicate with researchers, able to understand and comply with experimental requirements, voluntarily participate in the experiment, understand and sign a written informed consent form; 2) Age 18 and above, gender not limited; 3) Expected survival period of at least 3 months; 4) The ECOG score for physical fitness status ranges from 0 to 1; 5) Late stage malignant solid tumor patients diagnosed by histology or cytology as having failed standard treatment, lacking standard treatment, or refusing standard treatment; 6) According to RECIST 1.1 criteria, there must be at least one measurable target lesion; 7) Confirmed as FAP positive by 18F/68Ga FAPI PET scan; 8) Adequate organ function: a. Bone marrow reserve: neutrophil count = 1.5 × 109/L; Platelet count = 90 × 109/L; Hemoglobin = 90 g/L; b. Liver function: AST/ALT = 3 ? ULN, or subjects with liver metastasis2.8 g/dL; Total bilirubin = 1.5 ULN; c. Renal function: creatinine clearance rate = 50 mL/min (according to the Cockcroft Gault formula). 9) The subject has recovered from toxic reactions caused by previous treatment (= grade 1 or baseline before treatment), except for hair loss, vitiligo, etc; 10) For male or female subjects with fertility: agree to abstinence or use effective contraceptive methods, including intrauterine devices, for at least 24 weeks from the time of signing the ICF until the last dose of 177Lu FAPI FUSCC injection; 11)Agree to take radiation protection measures according to medical advice during the trial period.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1) Female subjects who are pregnant or breastfeeding, or have a positive baseline blood pregnancy test; 2) Individuals who have experienced severe allergic reactions to 177Lu FAPI FUSCC injection and 18F/68Ga components in the past; 3) Subjects who have received blood transfusion therapy within the previous 4 weeks of screening to meet the inclusion criteria; 4) Received any investigational medication within 28 days prior to the first dose, or participated in another clinical study at the same time (excluding: subjects participating in observational, non interventional clinical studies, or in the follow-up period of interventional clinical studies); 5) Received systemic anti-cancer treatment such as radiotherapy, chemotherapy, immunotherapy, or biological therapy within 4 weeks before the first administration; Or plan to use cytotoxic chemotherapy drugs, anti-tumor immunotherapy, radioligand therapy, or other similar anti-tumor drugs during the trial period; 6) History of other known malignant tumors within the past 5 years, excluding locally cured tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ; 7) Having primary central nervous system (CNS) malignant tumors; CNS metastatic subjects who have failed local treatment; Subjects who have no symptomatic brain metastases within 28 days prior to enrollment, or whose clinical symptoms are stable and do not require steroid hormones or other treatments for brain metastases, may be enrolled; 8) Individuals who are positive for hepatitis C virus antibodies (HCVAb), human immunodeficiency virus antibodies (HIV), and syphilis antibodies during screening; 9) During screening, hepatitis B surface antigen (HBsAg) positive patients also need to be tested for hepatitis B virus deoxyribonucleic acid (HBV-DNA). If the researchers determine that the patients are in the replication phase of viral activity, they cannot be included; 10) Patients who require immunosuppressive therapy for allogeneic organ transplantation; 11) Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment; 12) Serious cardiovascular clinical diseases or symptoms that may increase the safety risk of subjects, including: Congestive heart failure (NYHA classification>Grade II) within the past year; Unstable angina pectoris occurred within the past year; Myocardial infarction occurred within the past year; Malignant arrhythmias with clinical significance (excluding atrial fibrillation and paroxysmal supraventricular tachycardia); There is clinically significant QTcF prolongation (QTcF>470 ms, calculated using Fridericia's formula); 13) Significant clinical bleeding (such as gastrointestinal bleeding or intracranial bleeding) occurred within 14 days prior to the first use of medication; 14) Having undergone major surgery or suffered serious trauma within 28 days prior to the first use of medication; 15) Severe urinary incontinence, urinary dysfunction, or urinary tract obstruction; 16) Individuals who are unable to undergo PET/CT scans due to weight limitations or other reasons; 17)There are other situations that researchers believe may increase safety risks 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 ContactShaoli Song
Fudan University Shanghai Cancer Center
Outcome results
None listed