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This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled anti-CLDN18.2 mAbs (89Zr-NY005) PET imaging in patients with CLDN18.2 positive solid tumors.
After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of anti-CLDN18.2 mAbs(89Zr-NY005) and will undergo PET/CT scanning to determine uptake of 89Zr-NY005 in tumor lesions and normal tissues and organs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 89Zr-NY005 injection | Experimental | Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3 mCi) labeled anti-CLDN18.2 mAbs (89Zr-NY005) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-NY005 | Drug | 89Zr-NY005 injection followed by 89Zr-NY005 PET scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005) | Biodistribution of 89Zr-Anti-CLDN18.2 mAbs (NY005) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 89Zr-PET scans will be reported. | 1 year |
| Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005). | Area under the radioactivity (SUVs) versus time (time from injection) curve (AUC) will be derived by integration and reported. Other pharmacokinetic parameters including peak radioactive uptake (Cmax) and time (Tmax) in different organs, clearance and volume of distribution, evaluated using a biexponential model and non-compartmental analysis, will be reported. | 1 year |
| Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005). | Absorbed dose (radioactive uptake) estimates for different organs and tissues calculated with the AUCs and the OLINDA/EXM dosimetry program will be obtained and reported. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuxi No. 4 People's Hospital | Wuxi | Jiangsu | 214062 | China |
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