Safety, Pharmacokinetics, and Anticancer Activity of Actinium-225-Macropa-Pelgifatamab in Advanced Metastatic Castration-Resistant Prostate Cancer

The primary objective of this study is to evaluate the **safety** of the investigational treatment actinium-225-macropa-pelgifatamab (BAY3546828) in men with advanced **metastatic castration-resistant prostate cancer** (mCRPC). This is clinically relevant as it aims to determine the treatment's tolerability and potential adverse effects, which are critical for assessing its viability as a therapeutic option for this patient population.

The clinical trial involves a total of **162 participants** diagnosed with **metastatic castration-resistant prostate cancer**. The study population is exclusively male, with an age range that includes adults and older adults, specifically those aged 18 years and above. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided. The trial does not include a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits were not specified. The selection process aimed to ensure a representative sample of the target demographic, focusing on individuals with the specified medical condition. The trial's design and participant selection were conducted with adherence to ethical standards and scientific rigor.

The clinical trial is designed to evaluate the safety, pharmacokinetics, and anticancer activity of **actinium-225-macropa-pelgifatamab** in men with advanced **metastatic castration-resistant prostate cancer**. This study is a Phase 1 trial, which is typically the first stage in testing a new treatment in humans. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is August 31, 2023, with an anticipated end date of May 12, 2031, indicating a comprehensive study period to gather sufficient data.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational treatment or a control. Regular follow-up visits will be scheduled to monitor the participants' health, treatment response, and any adverse events. These visits are crucial for collecting data on the treatment's pharmacokinetics and safety profile. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted to evaluate the overall impact of the treatment.

The expected length of participant involvement will vary depending on individual response and tolerance to the treatment. However, the study is designed to accommodate the entire trial duration unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial's methodology and design are structured to ensure the collection of robust and reliable data, contributing to the understanding of the investigational treatment's potential benefits and risks in the target population.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to commence recruitment on August 31, 2023, with an estimated end date of May 12, 2031. Although specific efficacy endpoints and methods for measurement and analysis are not detailed, Phase 1 trials often utilize a combination of laboratory tests, imaging studies, and clinical assessments to gather data on the investigational product's effects. The trial will adhere to a predefined schedule for data collection and analysis, ensuring that all relevant efficacy parameters are systematically evaluated throughout the study duration.