Phase I Evaluation of [211At]At-Girentuximab Safety and Efficacy in Non-Muscle-Invasive Bladder Cancer Refractory to Standard Treatment

The primary objective of this first-in-human phase I trial is to evaluate the safety and tolerability of [211At]At-Girentuximab (ATO-101™) in individuals diagnosed with non-muscle-invasive bladder cancer that is refractory to standard treatment. This investigation is clinically significant for determining the initial human dose levels and the acceptable safety profile of this radiopharmaceutical. The secondary objectives include the assessment of the response of the therapeutic agent in the specified patient population.

The sponsor did not provide the total number of participants for this study. The study population consists of patients diagnosed with non-muscle-invasive bladder cancer that is refractory. The cohort includes both male and female individuals. The age range of the participants is categorized under specific age codes 3 and 4.

This Phase I clinical trial is designed to evaluate the safety, tolerability, and response of [211At]At-Girentuximab (ATO-101™) in patients diagnosed with non-muscle-invasive bladder cancer that is refractory to standard treatment. The study methodology involves a first-in-human approach to assess the pharmacological profile of the investigational agent. The research sequence begins with a screening visit to determine eligibility based on predefined criteria. Following successful screening, participants proceed through scheduled follow-up visits to monitor clinical outcomes and physiological responses. The process concludes with an end-of-study visit. The total duration of participant involvement will be determined by the clinical protocol, and early termination may occur if specific safety or efficacy conditions are met.

The assessment of efficacy in this Phase 1 clinical trial for non-muscle-invasive bladder cancer is not specified.