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)
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.
Age ≥18 years at the time of signing the informed consent form;
ECOG score 0-2;
Life expectancy ≥6 months;
A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;
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.
Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides.
Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET/CT.
Sequential
68Ga-NYM096 injection
DrugUsing a syringe to withdraw 68Ga-NYM096 injection, the dose will be administered via an intravenous injection
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
Incidence of abnormal laboratory test results, abnormal vital signs and ECG
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