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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 89Zr-CD147 1mCi±10% 10mg dose group | Experimental | The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg. |
|
| 89Zr-CD147 3mCi±10% 10mg dose group | Experimental | The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg. |
|
| 89Zr-CD147 5mCi±10% 10mg dose group | Experimental | The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-CD147 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value (SUV) | Standardized uptake value of tumor | Day 0-7 |
| standardized uptake value ratio (SUVR) | The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue | Day 0-7 |
| Radiation dose | Radiation dose of whole body and major tissues / organs of subjects after administration | Day 0-7 |
| Measure | Description | Time Frame |
|---|---|---|
| Terminal Half Time (T1/2) | Pharmacokinetic parameters | Day 0-7 |
| Clearance (CL) | Pharmacokinetic parameters | Day 0-7 |
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Inclusion Criteria:
Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
Patients must have an ECOG performance status of 0-1;
Patients must have a life expectancy ≥ 12 weeks;
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;
Patients must have ≥1 measurable lesion according to RECIST1.1 criteria;
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.;
Patients must have the ability to understand and sign an approved ICF.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Chen, PHD | Contact | 13700989831 | chenyue5523@126.com | |
| Lin Qiu, PHD | Contact | 15984011133 | qiulin17111210041@163.com |
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| Peak Plasma Concentration (Cmax) | Pharmacokinetic parameters | Day 0-7 |
| Area under the plasma concentration versus time curve (AUC) | Pharmacokinetic parameters | Day 0-7 |
| Distribution (dL) | Pharmacokinetic parameters | Day 0-7 |