Safety, Pharmacokinetics, and Efficacy of BAY 2416964 (AhR Inhibitor) and Pembrolizumab in Adults with Advanced Solid Tumors

The primary objective of this study is to evaluate the **safety** and **tolerability** of the study drug BAY 2416964, an AhR inhibitor, in combination with **pembrolizumab** in adults with advanced solid tumors. This investigation is clinically relevant as it aims to determine the maximum tolerated dose and assess the pharmacokinetics and pharmacodynamics of this combination therapy, which could potentially offer a new therapeutic option for patients with advanced malignancies.

The clinical trial involves a total of **45 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 to include a vulnerable population, indicating a focus on individuals who may have additional health considerations. The trial does not specify particular lifestyle factors such as diet or physical activity. The selection criteria for the trial population were not detailed by the sponsor.

The clinical trial is designed to evaluate the safety and pharmacokinetics of the **AhR inhibitor** BAY 2416964 in combination with pembrolizumab in adults with advanced solid tumors. This study is a Phase 3, randomized, double-blind, controlled trial, which aims to determine the maximum tolerated dose and assess the drug's efficacy against advanced solid cancers. The trial is expected to commence recruitment on July 20, 2023, and conclude by March 14, 2025, with an overall duration of approximately 20 months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the study drug combination or a control. Regular follow-up visits will be scheduled to monitor safety, drug levels, and therapeutic response. These visits will include physical examinations, laboratory tests, and imaging studies as necessary. The end-of-study visit will occur after the final treatment cycle, where comprehensive assessments will be conducted to evaluate the overall outcomes and any long-term effects.

The expected length of participant involvement in the trial is contingent upon individual response and tolerance to the treatment, with the possibility of early termination if adverse effects are observed or if the participant withdraws consent. Additionally, participants may be discontinued from the study if they do not adhere to the protocol requirements or if the investigator deems it in their best interest. The trial's design ensures rigorous monitoring and data collection to achieve its objectives while maintaining participant safety and scientific integrity.

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 in a Phase 3 study. The trial is scheduled to commence recruitment on July 20, 2023, with an estimated completion date of March 14, 2025. The efficacy assessment will be conducted through a series of pre-defined 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. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the therapeutic benefits of the investigational product. The trial's design will ensure that efficacy is assessed objectively and consistently throughout the study duration.