Clinical trial · Interventional
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors
89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors
NCT03638804CI-TRIAL-00036030unknownN/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 by using 89Zr-labeled KN035 (89Zr-KN035) PET imaging to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced 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-KN035 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 89Zr-KN035 injection
- interventionNames
- Diagnostic Test: 89Zr-KN035
Primary outcomes (1)
- measure
- Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- Number of adverse events as assessed by CTCAE v4.03
- timeFrame
- 6 months
- description
- All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria (main): 1. Patients voluntarily signed informed consent; 2. Age 18-75, male or female; 3. Patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology; 4. Patients with biopsy-proven PD-L1 positive; 5. ECOG score ≤ 0\~1; Life expectancy of at least 3 months; 6. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects. Exclusion Criteria(main): 1. Currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. If participating in a non-interventional clinical trial, it is not be excluded. 2. Patients with systemic or locally severe infections (CTCAE ≥ 2); 3. Patients with allergies or allergies to any component of the imaging agent or antibody; 4. Patients who cannot undergo PET/CT imaging; 5. Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia); 6. Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia; 7. Patients have significant QT/QTC interval prolongation during the screening period; 8. Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose; 9. Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered; 10. Previously received CD137 agonist or immune checkpoint blocking therapy; 11. Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L; 12. HIV antibody positive, active hepatitis B/C, and TB positive; 13. Patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol); 14. Patients with symptomatic ascites, pleural effusion, or hydropericardium; 15. Pregnant or lactating women, or planning to become pregnant or have children during this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.