3022 - STARBURST: Phase 2 Study of <sup>89</sup>Zr-girentuximab for PET Imaging of Solid Tumors Likely to Express High Levels of Carbonic Anhydrase IX (CAIX)

05:00pm - 06:00pm PT

Hall F

Screen: 20

POSTER

Presenter(s)

David Cade, MD - Telix Pharmaceuticals, Fishers, IN

F. Almaguel¹, J. Kiser², D. Murrey³, Q. Li⁴, J. Leahy⁵, S. A. Esfahani⁶, D. K. Heimburger⁷, J. Crowley², S. Shah⁸, K. Vadali⁸, and D. Cade⁸; ¹Biogenix Molecular, Miami, FL, ²Carilion Clinic, Roanoke, VA, ³Inland Imaging, Spokane, WA, ⁴Department of Radiology, University Hospitals, Case Western Reserve University, Cleveland, OH, ⁵Austin Radiological Association, Austin, TX, ⁶Massachusetts General Hospital, Boston, MA, ⁷Munson Healthcare, Traverse City, MI, ⁸Telix Pharmaceuticals, Melbourne, Australia

Purpose/Objective(s):

CAIX is a cell surface antigen that is widely expressed in many cancers including renal cell carcinoma, urothelial carcinoma, and triple negative breast cancer; thus, it is a potential target for imaging and therapy.⁸⁹Zr-girentuximab is a diagnostic radiopharmaceutical for PET imaging that targets CAIX and has demonstrated high diagnostic performance and favorable safety and tolerability profile for diagnosis and characterization of ccRCC. Patients with other CAIX-expressing cancers may benefit from a targeted theranostic pair, and ⁸⁹Zr-girentuximab could assist with patient selection for immuno-oncology therapy. ⁸⁹Zr-girentuximab imaging could also provide a cost-effective method for monitoring treatment response. In this study, patients with different tumor types likely to express CAIX will be evaluated for ⁸⁹Zr-girentuximab tumor uptake.

Materials/Methods:

This phase 2, multicenter, open-label study will evaluate feasibility of targeting CAIX for diagnostic and therapeutic applications. A minimum of 5 participants will be enrolled for each cancer type including but not limited to cervical, colorectal, esophageal, head and neck, liver, lung, ovarian, pancreatic, soft tissue sarcoma, and Von Hippel-Lindau-related lesions. Patients must have at least one non-central nervous system measurable target lesion (except with glioblastoma or hemangioblastoma) documented by conventional imaging performed within 60 days before dosing. Patients will receive a single administration of ⁸⁹Zr-girentuximab (37 MBq [1mCi]±10%, containing 10 mg of girentuximab) and will undergo PET/CT imaging 5 ± 2 days later.

The primary endpoint is the qualitative and quantitative assessment of ⁸⁹Zr-girentuximab uptake within individual tumors compared with measurable lesions detected by conventional imaging and evaluated per Standard Criteria Response Evaluation Criteria in Solid Tumors and Response Assessment in Neuro-Oncology. Analysis of each lesion will include maximum standardized uptake value (SUV), mean SUV, SUV corrected for lean mass, metabolic tumor volume, and tumor to background ratio. Efficacy of 89Zr-girentuximab will be based on the ability of PET/CT imaging to non-invasively evaluate CAIX tumoral expression in participants receiving the product compared with conventional imaging.

Tumor uptake of ⁸⁹Zr-girentuximab will be assessed per lesion (up to the 10 most active lesions). Qualitative visual analysis (presence or absence of localized uptake associated with tumor, as seen on contrast-enhanced CT, MRI and/or FDG PET/CT) will be used to evaluate concordance of tumor lesion detection between ⁸⁹Zr-girentuximab PET/CT and conventional imaging. Patient safety will be evaluated based on incidence and nature of adverse events and clinically significant changes in laboratory test values, vital signs, or physical exam. This study is ongoing.

Results: TBD

Conclusion: TBD