Dose-Escalation Study of BI 765049 in Patients with Advanced Colorectal, Gastric, or Pancreatic Carcinomas

The primary objective of this study is to evaluate the safety and tolerability of different doses of **BI 765049** in individuals with advanced **colorectal carcinoma (CRC)**, as well as cancers of the stomach or pancreas. This is clinically relevant as it aims to determine the optimal dosing regimen that maximizes therapeutic efficacy while minimizing adverse effects in patients with these advanced malignancies.

The clinical trial involves a total of **30 participants** diagnosed with **colorectal carcinoma (CRC)**. 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 varying doses of BI 765049 in patients with advanced **colorectal carcinoma (CRC)**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is April 30, 2025, with an anticipated completion date of May 12, 2027. Participants will be involved in the study for the duration of the trial, which spans approximately two years.

The trial will commence with an inclusion visit, also known as the screening visit, where potential participants will be assessed against the inclusion and exclusion criteria to determine eligibility. Following successful screening, participants will be randomized to receive either the investigational drug or a control. The study will include multiple follow-up visits at predetermined intervals to monitor the participants' health, assess the drug's efficacy, and record any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the trial.

The end-of-study visit will mark the conclusion of a participant's involvement in the trial. During this visit, final assessments will be conducted to gather comprehensive data on the long-term effects of the treatment. Participants may be withdrawn from the study early if they experience significant adverse effects, if they withdraw consent, or if they fail to comply with the study protocol. The trial's design ensures rigorous monitoring and data collection to support the evaluation of BI 765049's therapeutic potential in treating advanced colorectal carcinoma.

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 data. 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 April 30, 2025, with an estimated completion date of May 12, 2027. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The focus will be on evaluating the therapeutic impact of the intervention under investigation, with the aim of generating robust and reliable efficacy data.