Phase I Study of BI 1823911 Monotherapy and Combination Therapy in Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation

The primary objective of this study is to evaluate the efficacy and safety of different doses of **BI 1823911** administered alone and in combination with other therapeutic agents in patients with advanced cancer characterized by a **solid tumour** harboring a **G12C mutation**. This investigation is clinically relevant as it aims to determine the optimal dosing regimen that maximizes therapeutic benefit while minimizing adverse effects in this specific patient population. The study focuses on cancers with a **KRAS mutation**, which are known to be challenging to treat, thus addressing a significant unmet medical need in oncology.

The clinical trial involves a total of **7 participants** diagnosed with a **solid tumour harboring a G12C mutation**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion and exclusion criteria.

The clinical trial is designed to evaluate the efficacy and safety of **BI 1823911** in individuals with advanced cancer characterized by a **solid tumour harbouring G12C mutation**. This study is a Phase 3, randomized, double-blind, controlled trial, which aims to assess different doses of the investigational drug both as a monotherapy and in combination with other medications. The trial commenced on September 9, 2021, and is projected to conclude by December 27, 2024, encompassing a total duration of approximately 39 months.

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 enrollment, participants will attend regular follow-up visits at specified intervals to monitor treatment response, assess safety, and collect necessary data. The end-of-study visit will mark the completion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the trial is contingent upon the individual's response to the treatment and the overall study timeline. Conditions that may lead to early termination from the study include adverse reactions to the investigational drug, withdrawal of consent, or any other medical or ethical reasons deemed necessary by the study investigators. Participants will be closely monitored throughout the trial to ensure adherence to the protocol and to safeguard their well-being.

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

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. Therefore, a description of these elements is not possible based on the current data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is in Phase 3 and is scheduled to conclude on December 27, 2024. The recruitment for the trial began on September 9, 2021. The efficacy of the intervention will be assessed through parameters that are not specified in the provided data. The trial's primary and secondary endpoints, as well as the specific methods and tools for measuring efficacy, are not detailed in the available information. The trial is categorized under trial category 1, with a trial category ID of 34361. Further specifics regarding the endpoints and assessment tools are not provided in the source material.