Evaluating a new PET tracer for solid tumors

[68Ga]Ga-NOTA-SNA002 (PD-L1 PET Tracer) for PET/CT in Patients With Solid Tumors

This study is testing a new imaging agent to see if it helps doctors better identify solid tumors in patients aged 18-75.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: SmartNuclide Biopharma (industry)
• Drugs / interventions: prednisone
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05490264 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and uptake of the radiotracer [68Ga]Ga-NOTA-SNA002 in patients diagnosed with solid tumors. Participants will receive an injection of the tracer and undergo PET/CT scans to evaluate how well the tracer accumulates in tumor lesions compared to normal tissues. The study will include patients aged 18-75 with measurable solid tumors and will follow strict eligibility criteria to ensure safety and reliability of results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed solid tumors and measurable lesions.

Not a fit: Patients with non-solid tumors or those outside the age range of 18-75 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of imaging solid tumors, leading to better diagnosis and treatment planning.

How similar studies have performed: While this approach is innovative, similar studies using PET tracers have shown promise in enhancing tumor imaging.

Eligibility criteria

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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Liyan Miao, Ph.D — The First Affiliated Hospital of Soochow University
• Study coordinator: Hua Zhang

Conditions: Solid Tumor, Positron-Emission Tomography