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

NCT ID: NCT04989010

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-08-31

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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

89Zr-NY005 injection

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

Group Type: EXPERIMENTAL

89Zr-NY005

Intervention Type: DRUG

89Zr-NY005 injection followed by 89Zr-NY005 PET scan

Interventions

89Zr-NY005

89Zr-NY005 injection followed by 89Zr-NY005 PET scan

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuxi No. 4 People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wuxi No. 4 People's Hospital

Wuxi, Jiangsu, China

Countries

China

Facility Contacts

Chunjing Yu, MD.

Role: primary

ycj_wxd1978@163.com

15312238622

Other Identifiers

LS-CLDN18.2 001

Identifier Type: -

Identifier Source: org_study_id