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Bladder and Urothelial Cancer Treatments / Nanoplatforms for Cancer Theranostics · Journal article
Molecular Pharmaceutics · August 11, 2026
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This is a preclinical development study of a novel 89Zr-labeled immunoPET radiotracer targeting Nectin-4 in bladder cancer. The construct showed high radiochemical stability, efficient cellular internalization, and promising tumor uptake in xenograft models, but remains at the stage of proof-of-concept; human clinical evaluation is required before clinical utility can be established.
Preclinical radiopharmaceutical development study. Xenograft models of bladder cancer with high and variable Nectin-4 expression; no human subjects.. Intervention: [89Zr]Zr-DFO*-sq-Enfortumab immunoPET radiotracer.
Radiochemical stability of 99% through Day 12 in human serum In vitro antigen-specific cellular internalization of 80–85% In vivo tumor uptake of 17.4 ± 2.8% ID/g in high Nectin-4–expressing xenografts
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This work supports continued development of the radiotracer as a potential companion imaging strategy for enfortumab vedotin therapy, but clinicians should not consider this validated for patient use until clinical trials demonstrate diagnostic accuracy and clinical utility in human subjects.
Preclinical development of a novel radiotracer with in vitro and xenograft imaging data supporting feasibility; lacks clinical validation or patient studies required for clinical decision-making.
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This work supports continued development of the radiotracer as a potential companion imaging strategy for enfortumab vedotin therapy, but clinicians should not consider this validated for patient use until clinical trials demonstrate diagnostic accuracy and clinical utility in human subjects.
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Abstract Nectin-4–targeted imaging has emerged as a promising strategy for patient stratification in urothelial carcinoma, yet currently available radiotracers remain limited by rapid renal clearance, urinary background activity, or potential pharmacologic confounding associated with antibody-drug conjugate (ADC)-based constructs. To overcome some of these limitations, we developed a payload-free immunoPET radiotracer based on the native enfortumab antibody conjugated with the bifunctional chelator DFO*-sq and radiolabeled with zirconium-89 (89Zr). The resulting [89Zr]Zr-DFO*-sq-Enfortumab preserved Nectin-4–specific targeting while demonstrating high radiochemical stability in human serum ( 99% through Day 12). In vitro studies showed efficient antigen-specific cellular internalization (80–85%), prolonged intracellular retention, and evidence consistent with partial recycling of antibody-associated species. In vivo, [89Zr]Zr-DFO*-sq-Enfortumab exhibited sustained tumor uptake reaching 17.4 ± 2.8% ID/g in high Nectin-4–expressing xenografts and correlated with differential Nectin-4 expression across multiple bladder cancer models. Importantly, the full-length antibody platform enabled high-contrast visualization of pulmonary metastatic lesions and orthotopic bladder tumors despite some urinary background activity. Together, these findings demonstrate that payload-free [89Zr]Zr-DFO*-sq-Enfortumab provides a biologically relevant immunoPET platform for noninvasive assessment of variable Nectin-4 expression and support its further evaluation as a companion imaging strategy for Enfortumab Vedotin–based therapies.
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