Clinical trial · Interventional
Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET Imaging in Patients With CLDN18.2 Positive Solid Tumors
Safety Study of 89Zr-Anti-CLDN18.2 mAbs PET-CT Imaging in Patients With CLDN18.2 Positive Solid Tumors
NCT04989010CI-TRIAL-00053087unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Zr-NY005 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 89Zr-NY005 injection
- description
- Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3 mCi) labeled anti-CLDN18.2 mAbs (89Zr-NY005)
- interventionNames
- Drug: 89Zr-NY005
Primary outcomes (3)
- measure
- Evaluation of tissue distribution of 89Zr-Anti-CLDN18.2 mAbs(NY005)
- timeFrame
- 1 year
- description
- 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.
- measure
- Pharmacokinetic analysis of 89Zr-Anti-CLDN18.2 mAbs (NY005).
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.