Phase I Evaluation of MGY825 in Adults with Advanced Non-Small Cell Lung Cancer with or without NFE2L2/KEAP1/CUL3 Mutations

The primary objective of this Phase I study is to evaluate the safety and tolerability of **MGY825** in patients with advanced non-small cell lung cancer, with or without NFE2L2/KEAP1/CUL3 mutations. This is clinically relevant as it aims to determine the potential of MGY825 as a therapeutic option for this patient population, which may have limited treatment alternatives. The study does not specify any secondary objectives.

The clinical trial involves a total of **70 participants** diagnosed with **advanced non-small cell lung cancer**, with or without NFE2L2/KEAP1/CUL3 mutations. The study population includes both male and female adults, categorized within the age ranges of 18 to 64 years and 65 years and older. Participants were selected to include a vulnerable population, although specific selection criteria are not provided. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not disclosed detailed inclusion or exclusion criteria for this study.

The clinical trial is a **Phase I** study designed to evaluate the investigational product MGY825 in patients diagnosed with **advanced non-small cell lung cancer**, with or without NFE2L2/KEAP1/CUL3 mutations. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from July 21, 2022, to July 21, 2027, allowing for comprehensive data collection and analysis over a five-year period.

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. Regular follow-up visits will be scheduled to monitor the safety and efficacy of the treatment, as well as to collect necessary data for the study endpoints. The end-of-study visit will conclude 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 adherence to the study protocol. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any protocol deviations that compromise the integrity of the trial. Participants will be closely monitored throughout the study to ensure their safety and the integrity of the collected data.

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 lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to commence recruitment on July 21, 2022, with an estimated completion date of July 21, 2027. Although specific efficacy endpoints are not detailed, Phase 1 trials often utilize various parameters such as **biomarker** levels or symptom improvement scores to gather initial efficacy data. The methods and schedule for measuring, collecting, and analyzing these parameters are not specified, but they generally involve validated scales, laboratory tests, or patient-reported outcomes at predetermined timepoints. The trial's design and execution will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments.