Phase I Clinical Trial of TOS-358 in Adult Patients with Advanced Solid Tumors: Colorectal, Cervical, Endometrial, Gastric, Urothelial, Breast, Head and Neck, Ovarian, and NSCLC.

The primary objective of this study is to evaluate the safety and tolerability of **TOS-358** in adults with solid tumors. The study focuses on nine main solid tumors: colorectal, cervical, endometrial, gastric, urothelial, breast, head and neck, ovarian, and non-small cell lung cancers. Understanding the safety profile of TOS-358 is clinically relevant as it may inform future therapeutic strategies and dosing regimens for these malignancies.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range corresponding to categories 3 and 4, which typically includes adults and older adults. The trial focuses on individuals diagnosed with one of the nine main **solid tumors**: colorectal, cervical, endometrial, gastric, urothelial, breast, head and neck, ovarian, and non-small cell lung cancers. The participants are not from a vulnerable population, indicating a general health status that does not include significant vulnerabilities. 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 suggests that the sponsor has chosen not to release certain details about the trial's demographic and selection process.

The clinical trial is designed to evaluate the safety and efficacy of a new investigational drug in adults with **solid tumors**, specifically targeting nine main types: colorectal, cervical, endometrial, gastric, urothelial, breast, head and neck, ovarian, and non-small cell lung cancers. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know who is receiving the investigational drug or the placebo, thereby minimizing bias. The trial is expected to commence recruitment on February 29, 2024, and is projected to conclude by July 31, 2026, with an overall duration of approximately two and a half years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized into treatment groups and will attend regular follow-up visits at specified intervals to monitor their health, assess the drug's effects, and collect data on safety and efficacy. These visits will include physical examinations, imaging studies, and laboratory assessments. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the investigational drug's impact.

The expected length of participant involvement will vary depending on individual response and the study's progression, but it is anticipated to last until the trial's end date unless early termination is warranted. Conditions that may lead to early termination include adverse reactions, disease progression, or withdrawal of consent by the participant. The trial's design and procedures are meticulously planned to ensure the collection of robust and reliable data, contributing to the understanding of the investigational drug's potential benefits and risks in treating 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 in the provided data, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be elaborated upon. The trial documentation should be consulted for comprehensive information regarding the treatments involved in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on February 29, 2024, with an estimated completion date of July 31, 2026. The trial is categorized under phase 7, indicating a specific stage in the clinical research process. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to determine the treatment's effectiveness. The methodology for measuring efficacy will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design will incorporate appropriate tools and instruments to facilitate accurate efficacy assessments, although these are not specified in the available data.