Evaluation of Safety, Pharmacokinetics, Distribution，Radiation Safety and Sensitivity/Specificity of PET/CT Imaging With 68Ga-NYM096 in Participants With IRM

A Phase I Study Assessing the Safety, Pharmacokinetics, Radioactivity Distribution，Radiation Safety and Preliminary Diagnostic Performance of 68Ga-NYM096 Injection in Participants With Indeterminate Renal Masses

68Ga-NYM096 is a carbonic anhydrase IX (CAIX)-targeted imaging agent that is under clinical development as a non-invasive diagnostic imaging agent for the detection of clear cell renal cell carcinoma (ccRCC). The Phase 1 study is to evaluate the safety, pharmacokinetics, radioactivity distribution, radiation safety and preliminary diagnostic performance in participants with indeterminate renal masses (IRM)

This will be a prospective, open-label, single-center phase I study. Histological confirmation will serve as standard of truth, to assess sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), as well as accuracy of 68Ga-NYM096 PET/CT Imaging.

A total of 20~40 participants with IRM scheduled for surgical resection will be enrolled and assigned to two dose groups. Each participant will receive a single injection of the assigned dose; dose escalation within the same participant is not permitted. The study includes screening period, dosing/imaging period, safety follow-up visit, and surgery follow-up period.

Inclusion Criteria:

1. Imaging evidence of a single indeterminate renal mass on contrast-enhanced CT or MRI, with planned partial or radical nephrectomy to be performed within 90 days following administration of 68Ga-NYM096.
2. Age ≥18 years at the time of signing the informed consent form;
3. ECOG score 0-2;
4. Life expectancy ≥6 months;
5. Negative pregnancy test for women of childbearing potential, and participants (including male participants) agree to use effective contraception during the study and for at least 3 months after dosing;
6. Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures

Exclusion Criteria:

1. A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;
2. Participants diagnosed with other malignancies that may affect life expectancy or interfere with disease assessment, except for those with a history of malignancy that has been adequately treated and in remission for over 3 years, and those with adequately treated non-melanoma skin cancer.
3. Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides.
4. Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET/CT.
5. Received other investigational drugs before 68Ga-NYM096 PET/CT, within 5 half-lives of that drug or within 28 days after its last dose, whichever is longer.
6. Severe non-malignant diseases (e.g., psychiatric, infectious, autoimmune, or metabolic diseases) that may interfere with study objectives or, in the investigator's judgment, affect participant safety or compliance.
7. Participants with active chronic hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive with HBV DNA ≥ lower limit of detection), active hepatitis C (e.g., hepatitis C virus [HCV] antibody positive with HCV RNA ≥ lower limit of detection), human immunodeficiency virus (HIV) infection, or active syphilis infection (positive for both treponemal-specific and non-treponemal antibodies).
8. Inability to lie quietly and flat in the scanner during PET examination, or conditions such as claustrophobia preventing cooperation with PET examination.
9. Other situations where the investigator considers the participant unsuitable for this study