Phase I Evaluation of IDH305 in Patients with Advanced Malignancies Harboring IDH1R132 Mutations

The primary objective of this study is to evaluate the safety and tolerability of **IDH305** in patients with **advanced malignancies** that harbor **IDH1R132 mutations**. This is clinically relevant as it aims to determine the potential therapeutic benefits and adverse effects of IDH305 in a specific patient population with genetic mutations that may influence disease progression and treatment response.

The clinical trial involves participants diagnosed with **advanced malignancies** that harbor IDH1R132 mutations. The study population includes both male and female subjects, with an age range classified under category code 3, which typically corresponds to adults. The trial also includes a vulnerable population, although specific details regarding the nature of this vulnerability are not provided. The sponsor has not disclosed the total number of participants involved in the study. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been specified. The absence of detailed inclusion or exclusion criteria suggests that the focus is primarily on the presence of the specified genetic mutation in the malignancies. The sponsor has not provided further information regarding the trial's main objective or additional participant characteristics.

The clinical trial is designed to evaluate the safety and efficacy of a novel therapeutic agent in patients with **advanced malignancies** that harbor **IDH1R132 mutations**. This is a Phase I trial, which is typically the first stage of testing in human subjects and primarily focuses on assessing the safety profile of the investigational product. The trial follows a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from June 9, 2015, to October 24, 2026, allowing for comprehensive data collection and analysis over an extended period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific inclusion and exclusion criteria. This initial visit will involve a thorough medical assessment and baseline data collection. Following successful enrollment, participants will attend regular follow-up visits at predetermined intervals to monitor their health status, assess treatment response, and identify 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 investigational product's impact.

The expected length of participant involvement will vary depending on individual response to treatment and the occurrence of any adverse events. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure participant safety and data integrity throughout the study period.

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 in the provided data.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The estimated recruitment start date was June 9, 2015, with an estimated end date of October 24, 2026. Although specific efficacy endpoints and methods for measurement are not detailed, Phase 1 trials often utilize a combination of laboratory tests, imaging studies, and clinical assessments to gather data on the investigational product's effects. The analysis of efficacy parameters is conducted in accordance with the trial's protocol, ensuring that data collection and evaluation are systematic and scientifically rigorous.