Phase 1 Study on Safety and Pharmacokinetics of Selective MET Kinase Inhibitor DO-2 in Patients with Advanced or Refractory Solid Tumors

The primary objective of this study is to evaluate the **safety** and **pharmacokinetics** of the selective MET kinase inhibitor, DO-2, in patients with **advanced or refractory solid tumours**. This is clinically relevant as it aims to determine the tolerability and metabolic profile of DO-2, which could potentially offer a new therapeutic option for patients with limited treatment alternatives. The study does not specify any secondary objectives.

The clinical trial involves participants diagnosed with **advanced or refractory solid tumors**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion criteria have been specified. The absence of this data limits the ability to provide a comprehensive overview of the participant demographics and selection process.

The clinical trial is a **Phase 1** study designed to evaluate the safety and pharmacokinetics of a selective MET kinase inhibitor, DO-2, in patients with **advanced or refractory solid tumours**. 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 October 3, 2022, to December 31, 2024, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough review of the patient's medical history, physical examination, and necessary laboratory tests. Following successful screening, participants will be enrolled in the study and randomized to receive either the investigational drug or a control. Subsequent follow-up visits will be scheduled at regular intervals to monitor the participants' health, assess drug safety, and collect pharmacokinetic data. These visits will include physical examinations, laboratory tests, and assessments of any adverse events. The end-of-study visit will mark the conclusion of the participant's involvement, during which final evaluations will be conducted to gather comprehensive data on the drug's effects.

The expected length of participant involvement in the trial is approximately two years, contingent upon individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent, or non-compliance with study procedures. The trial is structured to ensure participant safety while providing valuable insights into the investigational drug's potential therapeutic benefits.

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.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. The information does not include parameters or endpoints used to evaluate efficacy, nor does it specify the methods, schedule, or tools for measuring, collecting, and analyzing efficacy parameters. The trial is identified as a Phase 1 study, with an estimated recruitment start date of October 3, 2022, and an estimated end date of December 31, 2024. Further details on efficacy assessment are not available in the provided data.