Clinical Trial · NCT07768306

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

Overview

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)

Sponsor

Norroy Bioscience Co., LTD

Phase

Phase 1

Contacts

Li Huo, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07768306

Drug / Compound

NYM096

Isotope(s):

Target(s):

CAIX

Ligand Class: Small Molecules

Eligibility

Inclusion

ECOG score 0-2;
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.

Exclusion

A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;
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).