Phase 1 Safety and Dose-Finding Study of 131I-TLX101 with Standard of Care in Newly Diagnosed Glioblastoma Multiforme Patients

The primary objective of this study is to evaluate the **safety** and determine the appropriate **dose** of 131I-TLX101 when used in conjunction with the standard of care in patients with newly diagnosed **glioblastoma multiforme (GBM)**. This is clinically relevant as it aims to establish a safe and effective treatment regimen that could potentially improve outcomes for patients with this aggressive brain tumor. No secondary objectives are provided in the available data.

The clinical trial involves a total of **6 participants** diagnosed with **glioblastoma multiforme (GBM)**. The study population includes both male and female subjects, with an age range that spans from young adults to middle-aged individuals. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed further details regarding the general health status of the participants or the selection process.

The clinical trial is designed to evaluate the safety and dosage of **131I-TLX101** in combination with standard care for patients with newly diagnosed **glioblastoma multiforme (GBM)**. This study is a Phase 1 trial, characterized by a randomized, double-blind, and controlled design, ensuring that neither the participants nor the researchers know who is receiving the experimental treatment versus the control. The trial is expected to run from August 2, 2023, with an estimated completion date of December 31, 2027.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled in the study and will attend regular follow-up visits to monitor their health and response to the treatment. These visits are crucial for collecting data on the safety and efficacy of the treatment. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted to gather comprehensive data on the trial's outcomes.

The expected length of participant involvement will vary depending on individual response and the study's progression, but it is anticipated to last until the trial's completion. Conditions that may lead to early termination from the study include adverse reactions to the treatment, withdrawal of consent, or any significant protocol deviations. The trial's methodology and design are structured to ensure the collection of reliable and valid data, contributing to the understanding of the treatment's potential benefits and risks for patients with **glioblastoma multiforme**.

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 treatments 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 offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating it is in the advanced stages of clinical research. The estimated recruitment start date is August 2, 2023, with an anticipated completion by December 31, 2027. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 3 trials typically focus on confirming the effectiveness of a treatment, monitoring side effects, and collecting information that will allow the treatment to be used safely. The trial will likely involve systematic data collection and analysis to evaluate the treatment's impact on the disease condition. The methods and schedule for measuring efficacy, as well as the tools or instruments used, are not specified in the available data. The trial's design will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments.