Phase Ib Dose-Escalation Study of [177Lu]Lu-NeoB with Radiotherapy and Temozolomide in Newly Diagnosed Glioblastoma and as Monotherapy in Recurrent Glioblastoma

The primary objective of this study is to evaluate the safety and determine the optimal dose of **[177Lu]Lu-NeoB** when used in combination with radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed **glioblastoma**, as well as to assess its efficacy as a single agent in patients with recurrent glioblastoma. This is clinically relevant as it aims to improve treatment outcomes and provide new therapeutic options for a condition with limited effective treatments.

The clinical trial involves a total of **14 participants** diagnosed with **glioblastoma**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The general health status of the participants is not detailed, nor are any lifestyle considerations such as diet, physical activity, or habits. The trial does not specify any particular lifestyle factors that may influence the study outcomes.

The clinical trial is designed to evaluate the efficacy and safety of **[177Lu]Lu-NeoB** in combination with radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed **glioblastoma**, as well as its use as a single agent in recurrent cases. This study is structured as a Phase Ib dose-finding trial, employing a randomized, double-blind, and controlled methodology to ensure robust and unbiased results. The trial is expected to commence recruitment on March 31, 2024, and is projected to conclude by August 28, 2031, encompassing a comprehensive duration to adequately assess the treatment outcomes.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor treatment response, assess safety, and manage any adverse events. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather data on the long-term effects of the treatment.

The expected length of participant involvement will vary depending on individual response to treatment and the specific arm of the study they are enrolled in. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial's design and procedures are meticulously crafted to ensure the collection of high-quality data while prioritizing participant safety and adherence to ethical standards.

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

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided dataset. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on March 31, 2024, with an estimated completion date of August 28, 2031. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's duration and phase indicate a comprehensive evaluation of the investigational product's efficacy, although further specifics on the endpoints and assessment tools are not provided in the current dataset.