Evaluation of M9466 Monotherapy and Combination Therapy in Patients with Advanced Solid Tumors

The primary objective of the study titled "M9466 Alone or in Combination in Advanced Solid Tumors (DDRiver 501)" is not explicitly stated. However, the study focuses on evaluating the effects of the investigational product M9466, either as a monotherapy or in combination, in patients with **advanced solid tumors**. This is clinically relevant as advanced solid tumors often present significant treatment challenges, and new therapeutic options could potentially improve patient outcomes. No secondary objectives are provided in the available data.

The clinical trial involves a total of **75 participants** diagnosed with **advanced solid tumors**. The study population includes both male and female subjects, encompassing an age range that includes adults and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided. The trial population includes individuals from a vulnerable population, indicating a need for careful ethical considerations. Lifestyle factors such as diet, physical activity, or habits were not specified. The sponsor did not provide detailed information regarding the general health status of the participants.

The clinical trial is designed to evaluate the efficacy and safety of **M9466** alone or in combination for the treatment of **advanced solid tumors**. This study is a Phase 3, randomized, double-blind, controlled trial, which aims to provide robust data on the therapeutic potential of the investigational product. The trial is expected to commence recruitment on November 1, 2024, and is projected to conclude by March 26, 2026. Participants will be involved in the study for the duration of the trial, with specific timelines for individual involvement determined by the study protocol.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Throughout the trial, participants will attend regular follow-up visits to monitor their response to treatment and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit marks the conclusion of a participant's involvement, where final assessments are conducted to evaluate the overall outcomes of the treatment.

Participant involvement is expected to last until the end of the trial, unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, withdrawal of consent, or any other protocol-defined criteria that compromise participant safety or data integrity. The trial's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, providing a comprehensive framework for evaluating the investigational product's impact on advanced solid tumors.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. The absence of these details suggests that the focus is primarily on the experimental medication, although further clarification would be necessary to confirm this aspect of the trial design.

Due to the lack of specific information, it is not possible to provide additional relevant details about drug administration, dosing schedules, or participant compliance monitoring. The trial documentation does not include any data on the product's authorization status, pharmaceutical form, or the origin of the active substances involved. Consequently, a comprehensive description of the treatments used in this clinical trial cannot be fully articulated based on the current data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on November 1, 2024, with an estimated completion date of March 26, 2026. The efficacy of the investigational treatment will be evaluated using specific parameters, although these parameters are not detailed in the provided data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data. The trial's design and execution will adhere to rigorous standards typical of Phase 3 studies, ensuring that the results are reliable and scientifically valid. The trial's primary focus is to determine the treatment's effectiveness in the specified medical condition, which is not explicitly mentioned in the data. The study will be conducted in accordance with established clinical trial protocols, ensuring that all assessments are performed consistently and objectively throughout the trial duration.