Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors

Not Applicable

• Conditions: Solid Tumor, Adult
• Interventions: Drug: 89Zr-NY005

• Registration Number: NCT04989010
• Lead Sponsor: Wuxi No. 4 People's Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-23
• Last Update Submitted: 2021-07-23
• Study Start: 2021-08-01
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients voluntarily signed informed consent, and be able to complete the trial according to the requirement of the scheme;
2. Aged 18-80, male or female;
3. The clinical diagnosis was gastric cancer, esophageal cancer and pancreatic cancer;
4. Patients with biopsy-proven CLDN18.2 positive;
5. Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
6. At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
7. ECOG score ≤ 0~3; Life expectancy of at least 3 months;
8. ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit.
9. Other routine examinations are within the normal range or considered acceptable by the researchers.

Exclusion Criteria

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
89Zr-NY005 injection	89Zr-NY005	Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3 mCi) labeled anti-CLDN18.2 mAbs (89Zr-NY005)

Primary Outcome Measures

Name	Time	Method
Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005).	1 year	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.
Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005)	1 year	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.
Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005).	1 year	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.

Trial Locations

Locations (1)

Wuxi No. 4 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China