Phase I Study of DS-2243a in Patients with Advanced Solid Tumors

The primary objective of this study is to evaluate the safety and tolerability of **DS-2243a** in participants with **advanced solid tumors**. This is clinically relevant as it aims to determine the potential of DS-2243a as a therapeutic option for patients with these challenging malignancies, where treatment options may be limited. The study seeks to identify any adverse effects and establish a safety profile for future clinical development.

The clinical trial involves a total of **105 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 or physical activity. 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.

The clinical trial is designed to evaluate the safety and efficacy of a novel investigational product in participants with **advanced solid tumors**. This is a Phase 1 trial, which is the initial phase in clinical research aimed at assessing the safety profile of the investigational product. 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 March 1, 2025, to July 31, 2029, allowing for comprehensive data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, eligibility criteria will be assessed to confirm the participant's suitability for the trial. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor safety, collect data, and assess the investigational product's effects. The trial will conclude with an end-of-study visit, where final assessments will be conducted, and participants will be debriefed on their involvement in the study.

The expected length of participant involvement in the trial will vary depending on individual response and the investigational product's safety profile. Participants may be subject to early termination from the study if they experience adverse events, fail to comply with study procedures, or withdraw consent. The trial's design and procedures are structured to ensure participant safety while gathering critical data on the investigational product's potential therapeutic benefits for individuals with 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 of the experimental medication 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 addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be provided. The trial documentation does not include any additional relevant information about drug administration or participant compliance monitoring.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of March 1, 2025, and an estimated end date of July 31, 2029. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve standard methodologies appropriate for a Phase 1 study. These may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure efficacy. The schedule for measuring and collecting data will be aligned with the trial's objectives and duration, ensuring comprehensive analysis of the efficacy parameters. The trial will adhere to rigorous standards to ensure the reliability and validity of the efficacy assessments.