Phase I Open-label Dose-escalation Study of Intravenous PM14 in Patients with Advanced Solid Tumors

The primary objective of this study is to evaluate the **pharmacokinetics** and safety profile of PM14 when administered intravenously to patients with **advanced solid tumors**. This is clinically relevant as it aims to determine the appropriate dosage and potential therapeutic effects of PM14, which could contribute to the development of new treatment options for patients with these challenging malignancies.

The clinical trial involves a total of **35 participants** diagnosed with **advanced solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. 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, physical activity, or habits. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria. The selection process aimed to encompass a diverse demographic within the specified age range, ensuring a comprehensive evaluation of the treatment's effects across a broad spectrum of individuals with the condition.

This clinical trial is a **Phase I**, open-label, dose-escalating study designed to evaluate the clinical and pharmacokinetic properties of PM14 when administered intravenously to patients with **advanced solid tumors**. The trial commenced on September 4, 2017, and is projected to conclude by April 30, 2025. The study employs a non-randomized, open-label design, allowing for the assessment of safety, tolerability, and pharmacokinetics of the investigational drug in a specific patient population. Participants will be involved in the study for a duration that aligns with the trial's objectives and dosing schedule, with the possibility of early termination based on safety concerns or withdrawal of consent.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility criteria are assessed to ensure participants meet the necessary conditions for enrollment. Following successful screening, participants will undergo a series of follow-up visits, which are structured to monitor the drug's effects, collect pharmacokinetic data, and ensure participant safety. These visits will occur at predetermined intervals throughout the study duration. The end-of-study visit will mark the conclusion of a participant's involvement, during which final assessments will be conducted to gather comprehensive data on the investigational drug's impact.

Participants are expected to adhere to the study protocol, with involvement lasting until the completion of the trial or until specific conditions necessitate early withdrawal. Such conditions may include adverse reactions, non-compliance with study procedures, or any other factors that compromise participant safety or data integrity. The trial's design and procedures are meticulously structured to ensure the collection of robust and reliable data, contributing to the understanding of PM14's potential therapeutic benefits in treating advanced solid tumors.

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 protocols accurately.

The clinical trial is designed to assess the efficacy of the investigational treatment over a specified period. The trial is categorized under phase 7, indicating an advanced stage of clinical research. The estimated recruitment start date was September 4, 2017, with an anticipated end date of April 30, 2025. Efficacy assessments will be conducted at predetermined intervals throughout the trial duration. The specific parameters or endpoints used to evaluate efficacy, as well as the methods and schedule for measuring, collecting, and analyzing these parameters, are not detailed in the provided data. The trial will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy outcomes.