Solid Tumor
Conditions
Brief summary
The primary objective of this study is to observe the distribution of 89Zr-CD147 and radiation dosimetry characteristics in patients with solid tumors. The secondary objective is to observe the pharmacokinetic characteristics of 89Zr-CD147 in patients with solid tumors. This study is a single-center, open-lable study, including 89Zr-CD147 1mCi±10%，89Zr-CD147 3mCi±10% and 89Zr-CD147 5mCi±10% dose group. The trial is expected to last for 2 years from the first patient signing the consent form to the end of the trial.
Detailed description
Antibody based positron emission tomography (immuno-PET) imaging is of increasing importance to visualize and characterize tumor lesions. Additionally, it can be used to identify patients who may benefit from a particular therapy and monitor the therapy outcome.
Interventions
DRUG89Zr-CD147
The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.
Sponsors
Sinotau Pharmaceutical Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female; 2. Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ; 3. Patients must have an ECOG performance status of 0-1; 4. Patients must have a life expectancy ≥ 12 weeks; 5. Patients must have adequate organ function: White blood cell (WBC) count≥4.0x10\^9/L or absolute neutrophil count (ANC) ≥1.5 x 10\^9/L, Platelets ≥100 x 10\^9/L, Hemoglobin≥ 90g/L ; thrombin time or Activated partial thromboplastin time≤1.5ULN; liver and renal function: Total bilirubin≤1.5ULN (upper limit of normal), Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≤2.5ULN or ≤5ULN (subjects with liver metastasis), alkaline phosphatase (ALP)≤ 2.5ULN (if there is bone metastasis or liver metastasis ALP≤4.5ULN). Urea (BUN)≤1.5ULN, creatinine≤1.5ULN; 6. Patients must have ≥1 measurable lesion according to RECIST1.1 criteria; 7. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.; 8. Patients must have the ability to understand and sign an approved ICF.
Exclusion criteria
1. There are any of the following conditions, such as brain metastasis (except for asymptomatic primary or metastatic brain tumors that do not need treatment), carcinomatous meningitis, myocardial infarction (within 6 months before enrollment), unstable angina pectoris, or high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (cardiac function grade III-IV), pulmonary embolism, deep venous thrombosis, Infections that need to be treated with intravenous antibiotics within 2 weeks, and immunosuppressant therapy after organ transplantation; 2. Primary central nervous system tumor; 3. HBV DNA≥1000 copies/ml; 4. HCV-RNA≥1000 copies/ml; 5. People with positive antibodies to HIV or syphilis; 6. Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease; 7. Women who are pregnant, breastfeeding or planning pregnancy; 8. People who are known to be allergic to the study preparation or its auxiliary materials; 9. People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders; 10. Patients who cannot lie for half an hour; 11. Patients who are allergic to any component of the imaging agent or antibody; 12. Patients who cannot accept PET/CT imaging; 13. Situations that other researchers consider unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value (SUV) | Day 0-7 | Standardized uptake value of tumor |
| standardized uptake value ratio (SUVR) | Day 0-7 | The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue |
| Radiation dose | Day 0-7 | Radiation dose of whole body and major tissues / organs of subjects after administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Day 0-7 | Pharmacokinetic parameters |
| Terminal Half Time (T1/2) | Day 0-7 | Pharmacokinetic parameters |
| Distribution (dL) | Day 0-7 | Pharmacokinetic parameters |
| Clearance (CL) | Day 0-7 | Pharmacokinetic parameters |
| Peak Plasma Concentration (Cmax) | Day 0-7 | Pharmacokinetic parameters |
Contacts
Primary ContactYue Chen, PHD
Backup ContactLin Qiu, PHD
Outcome results
None listed