Phase I Study of BI 764532 Dose Tolerability in Patients with DLL3-Positive Glioma

The primary objective of this study is to evaluate the **tolerability** of different doses of BI 764532 in individuals diagnosed with **glioma expressing DLL3**. This is clinically relevant as determining the optimal dose is crucial for minimizing adverse effects while maximizing therapeutic efficacy in patients with this specific type of brain tumor.

The clinical trial involves a total of **10 participants** diagnosed with **glioma expressing DLL3**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected without targeting any vulnerable populations. The general health status of the participants is not specified, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is designed to evaluate the **tolerability** of varying doses of BI 764532 in individuals diagnosed with **glioma expressing DLL3**. This study is structured as a Phase 3, randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The trial is expected to commence recruitment on March 5, 2024, and is projected to conclude by August 17, 2026, encompassing a total duration of approximately two and a half years.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This visit is crucial for confirming the presence of **glioma expressing DLL3** and ensuring that participants meet all necessary inclusion criteria while not falling under any exclusion criteria. Following successful screening, participants will be randomized into different dosing groups. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health, assess the drug's tolerability, and collect data on any adverse events. These visits are essential for evaluating the primary and secondary endpoints of the trial.

The end-of-study visit marks the final assessment of the participants, where comprehensive evaluations are conducted to gather conclusive data on the drug's effects. The expected length of participant involvement in the trial is contingent upon the dosing schedule and the overall trial timeline. However, certain conditions, such as significant adverse reactions or withdrawal of consent, may necessitate early termination from the study. Participants' safety and well-being are prioritized throughout the trial, with continuous monitoring to ensure adherence to ethical standards and regulatory requirements.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the experimental medication's **pharmaceutical form**, **dosage**, or **route of administration**. Furthermore, there is no information on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

As the source data does not provide any information about the substances used in the trial, it is not possible to describe the **active substances** or their **origin**. Additionally, there is no information on the **product authorization status** or the **sponsor product code**. Consequently, the description of the treatments used in this clinical trial remains incomplete due to the lack of available data.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating a focus on confirming the effectiveness of the intervention in a larger patient population. The trial is scheduled to commence recruitment on March 5, 2024, with an estimated completion date of August 17, 2026. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 3 trials typically involve comprehensive assessments to determine the therapeutic benefit of the intervention. These assessments may include various clinical measures, laboratory tests, and patient-reported outcomes, conducted at predetermined intervals throughout the study duration. The data collected will be analyzed to evaluate the intervention's impact on the targeted medical condition, ensuring a rigorous and objective assessment of efficacy.