Clinical trial NCT04989010: Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors
Official title: Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET-CT Imaging in Patients With CLDN18.2 Positive Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor, Adult
Lead sponsor: Wuxi No. 4 People's Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005)
timeFrame: 1 year
measure: Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005).
timeFrame: 1 year
measure: Dosimetry estimates of 89Zr-Anti-CLDN18.2 mAbs (NY005).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Wuxi No. 4 People's Hospital
state: Jiangsu
Study officials:
References: