Phase I Study of OKI-219 Monotherapy and in Combination with Endocrine or HER2-Targeted Therapy in Advanced Solid Tumors and Breast Cancer

The primary objective of this study is to evaluate the safety and tolerability of **OKI-219** when administered alone and in combination with endocrine therapy or HER2-targeted therapy in patients with **advanced solid tumors** and **advanced breast cancer**. This is clinically relevant as it aims to determine the potential of OKI-219 as a therapeutic option for these conditions, which are often challenging to treat due to their advanced nature.

The clinical trial involves a total of **68 participants** diagnosed with **advanced solid tumors** and **advanced breast cancer**. 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 to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of OKI-219, both as a monotherapy and in combination with endocrine therapy or HER2-targeted therapy, in patients with **advanced solid tumors** and **advanced breast cancer**. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial is from June 3, 2024, to June 30, 2026, allowing for comprehensive data collection and analysis over a two-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 participants' health status, treatment response, and any adverse events. These visits are crucial for ensuring participant safety and for collecting data on the primary and secondary endpoints of the study. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the trial is approximately two years, aligning with the overall trial duration. However, certain conditions may lead to early termination from the study, such as the occurrence of significant adverse events, withdrawal of consent, or non-compliance with the study protocol. The trial is structured to maintain the highest ethical standards and to prioritize participant safety throughout its course.

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 through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is June 3, 2024, with an anticipated end date of June 30, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to gather data on the investigational product's effects. The schedule for measuring and collecting efficacy data is typically aligned with the trial's protocol, ensuring systematic and consistent data collection throughout the study duration. The analysis of efficacy data will be conducted using appropriate statistical methods to determine the investigational product's potential therapeutic benefits.