Dose-Escalation Study of BI 907828 with BI 754091 and BI 754111 or BI 907828 with BI 754091 in Patients with Advanced Solid Tumors

The primary objective of this study is to evaluate the safety and efficacy of different doses of **BI 907828** (brigimadlin) in combination with **BI 754091** (ezabenlimab) and **BI 754111**, or **BI 907828** (brigimadlin) in combination with **BI 754091** (ezabenlimab) in patients with advanced **solid tumors**. This is clinically relevant as it aims to determine the optimal dosing regimen that maximizes therapeutic benefits while minimizing adverse effects in this patient population.

The clinical trial involves a total of **60 participants** diagnosed with **advanced solid tumors**. 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 efficacy and safety of **BI 907828** (brigimadlin) in combination with **BI 754091** (ezabenlimab) and **BI 754111**, or **BI 907828** in combination with **BI 754091** in patients with **advanced solid tumors**. This is a Phase 3, randomized, double-blind, controlled trial. The estimated duration of the trial is approximately four years, with recruitment starting on June 22, 2022, and an estimated end date of May 30, 2026.

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. The trial will include multiple follow-up visits to monitor the participants' response to the treatment and to assess any adverse effects. These visits will be scheduled at regular intervals throughout the study period. The end-of-study visit will occur after the completion of the treatment phase, where final assessments will be conducted to evaluate the overall outcomes of the trial.

The expected length of participant involvement will vary depending on individual response to treatment and the specific arm of the trial they are assigned to. Participants may be subject to early termination from the study if they experience significant adverse effects, if their disease progresses beyond a certain point, or if they withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its **pharmaceutical form**, dosage, route, or frequency of administration. Additionally, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, that may be used in the study. Furthermore, the documentation lacks details on drug administration, dosing schedules, and participant compliance monitoring. As such, no further description of the treatments used in this clinical trial can be provided based on the available data.

The clinical trial is a Phase 3 study with an estimated recruitment start date of June 22, 2022, and an estimated end date of May 30, 2026. Efficacy will be assessed through the evaluation of primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured schedule for measuring, collecting, and analyzing efficacy parameters, consistent with standard practices in Phase 3 trials. The methods and tools for efficacy assessment are not specified in the available information. The trial is categorized under trial category 1, with a trial category ID of 58603.