Phase I Evaluation of [177Lu]Lu-FF58 in Patients with Recurrent Glioblastoma Multiforme, Advanced Pancreatic Ductal Adenocarcinoma, and Gastroesophageal Adenocarcinoma

The primary objective of this phase I study is to evaluate the safety and tolerability of **[177Lu]Lu-FF58** in patients with advanced solid tumors, specifically targeting **recurrent glioblastoma multiforme (GBM)**, **locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)**, and **locally advanced unresectable or metastatic gastroesophageal adenocarcinoma (GEA)**. The clinical relevance of this study lies in its potential to provide a novel therapeutic option for these challenging malignancies, which are often associated with poor prognosis and limited treatment options.

The clinical trial involves a total of **61 participants** diagnosed with **recurrent glioblastoma multiforme (GBM)**, locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC), and locally advanced unresectable or metastatic gastroesophageal adenocarcinoma (GEA). The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, indicating adult participants. The trial population was selected to include a vulnerable population, although specific selection criteria are not provided. Participants' general health status is not detailed, nor are any lifestyle considerations such as diet or physical activity. The sponsor has not disclosed specific inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the safety and efficacy of **[177Lu]Lu-FF58** in patients with advanced solid tumors, specifically targeting **recurrent glioblastoma multiforme (GBM)**, **locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)**, and **locally advanced unresectable or metastatic gastroesophageal adenocarcinoma (GEA)**. This is a phase I trial, employing a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The trial is expected to commence on September 27, 2023, and conclude by November 21, 2025, with the overall duration spanning approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Regular follow-up visits will be scheduled to monitor the participants' health status, treatment response, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to evaluate the long-term effects of the treatment.

The expected length of participant involvement in the trial is contingent upon the individual's response to the treatment and the occurrence of any adverse events. Participants may be subject to early termination from the study if they experience significant adverse reactions, fail to comply with the study protocol, or withdraw consent. The trial is structured to ensure participant safety and the integrity of the collected data, adhering to ethical standards and regulatory requirements throughout its duration.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

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. Therefore, a description of these elements is not possible based on the current data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on September 27, 2023, with an estimated completion date of November 21, 2025. The trial is categorized under phase 7, indicating a specific stage in the clinical research process. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to determine the treatment's effectiveness. The methodology for measuring efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design will incorporate appropriate tools and instruments to facilitate accurate efficacy assessments, although these are not specified in the available data.