Phase 1 Evaluation of NG-350A and Pembrolizumab in Patients with Metastatic or Advanced Epithelial Tumors

The primary objective of this Phase 1 study is to evaluate the safety and tolerability of **NG-350A** in combination with **pembrolizumab** in patients with **metastatic cancer** or advanced **epithelial tumours**. This is clinically relevant as it aims to determine the potential of this combination therapy to manage or treat these aggressive cancer types, which are often resistant to standard treatments. The study will provide insights into the adverse effects and optimal dosing regimens, which are crucial for the development of effective therapeutic strategies for these conditions.

The clinical trial involves a total of **113 participants** diagnosed with **epithelial tumors** and **metastatic 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 without targeting any vulnerable populations. The general health status of the participants is not specified, but they are likely to be individuals with a diagnosis of the specified medical conditions. No specific lifestyle considerations such as diet, physical activity, or habits are mentioned in the available data. 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 safety and efficacy of NG-350A in combination with **pembrolizumab** for patients with **metastatic cancer** or advanced **epithelial tumours**. This study is a Phase 1 trial, which is typically the first stage in testing a new treatment in humans. 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 is from October 1, 2023, to December 31, 2026, allowing for comprehensive data collection and analysis over this period.

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 screening, participants will be enrolled in the study and will attend regular follow-up visits to monitor their response to the treatment and any potential side effects. These visits are crucial for assessing the primary and secondary endpoints of the trial. The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement will vary depending on individual response and the progression of the disease, but it is anticipated to last throughout the trial's duration unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the treatment, withdrawal of consent, or significant disease progression that warrants alternative therapeutic interventions. The trial is structured to ensure participant safety and the integrity of the data collected, adhering to rigorous scientific and ethical standards.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is scheduled to commence recruitment on October 1, 2023, with an estimated completion date of December 31, 2026. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Efficacy assessments will be conducted throughout the trial period, although specific parameters or endpoints for evaluating efficacy are not detailed in the provided data. The trial will adhere to a structured schedule for measuring and collecting data, ensuring that all assessments are conducted systematically and consistently. The analysis of efficacy data will be performed using scientifically validated methods, although the specific tools or instruments to be used are not specified. The trial's design and execution will follow rigorous standards to ensure the reliability and validity of the efficacy outcomes.