Clinical trial · Interventional
[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors
NCT05490264CI-TRIAL-00072036unknownEarly Phase 1ClinicalTrials.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)
The purpose of this study is to evaluate the safety of \[68Ga\]Ga-NOTA-SNA002 and investigate the uptake of \[68Ga\]Ga-NOTA-SNA002 in patients with solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Positron-Emission Tomography(PET) | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-NOTA-SNA002 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-NOTA-SNA002
- description
- A dose of 1mCi-5mCi of \[68Ga\]Ga-NOTA-SNA002 between 0.1mg to 0.9mg will be administered intravenously over 5minutes in Day 1 of subject enrollment
- interventionNames
- Biological: [68Ga]Ga-NOTA-SNA002
Primary outcomes (5)
- measure
- Incidence of adverse events
- timeFrame
- Time of infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) through Visit(Day 6)
- description
- The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of \[68Ga\]Ga-NOTA-SNA002.
- measure
- Changes of vital signs in participants compared with baseline results.
- timeFrame
- Baseline and 6 hours after infusion of [68Ga]Ga-NOTA-SNA002 (Day 1) and 2 hours after tumor biopsy(Day 2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years (including boundary values); 2. Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF); 3. Performance status (ECOG) score 0-2 points (see Appendix 1 for details); 4. Basal heart rate 60-100 beats/min (including boundary values); 5. Blood pressure measurement \< hypertension grade 1 level (including a history of hypertension, systolic blood pressure \< 140 and diastolic blood pressure \< 90 mmHg by exercise or drug treatment); 6. Patients with confirmed solid tumors; 7. Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1); 8. Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FluroDeoxyGlucose(FDG) PET/CT results are acceptable); 9. Patients obtained with immunohistochemical PD-L1 expression results within the previous month. Exclusion Criteria: 1. Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment; 2. Those who have extremely poor nutritional status and cannot tolerate the trial; 3. Known or suspected evidence of active autoimmune disease; 4. Patients taking high doses of hormones, such as more than 20mg of hydrocortisone or 5mg of prednisone in the morning and more than 10mg of hydrocortisone or 2.5mg of prednisone at night; 5. Those with known severe allergy to SNA002, similar drugs or excipients; 6. Patients with brain metastases; 7. Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies; 8. Women who are pregnant or breastfeeding. 9. Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.