Investigation of EOS301984 in Adult Patients with Advanced Solid Tumors
- Trial ID
- 2023-503844-14-00
- Protocol
- APT-008
- Sponsor
- iTeos Belgium
Trial statistics
Diseases & Conditions
Objectives
The primary objective of the study is to evaluate the safety and efficacy of **EOS301984** in adult participants with **advanced solid tumors**. This is clinically relevant as advanced solid tumors often present significant treatment challenges, and new therapeutic options are needed to improve patient outcomes. The study aims to assess the potential of EOS301984 to provide clinical benefits in this patient population.
Participants
The clinical trial involves participants diagnosed with **Advanced Solid Tumors**. The study population includes both male and female subjects, with an age range spanning from young adults to older adults. The trial does not specifically target a vulnerable population. However, the sponsor has not provided information regarding the total number of participants involved in the study. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified by the sponsor.
Plans and Procedures
The clinical trial is designed to evaluate the safety and efficacy of a new investigational product in adult participants with **advanced solid tumors**. This study is a Phase 1 trial, which is typically the first stage of testing in human subjects and focuses on assessing the safety profile, dosage tolerance, and pharmacokinetics of the investigational product. The trial employs a randomized, double-blind, controlled design to ensure unbiased results and to compare the investigational product against a placebo or standard treatment. The estimated duration of the trial is approximately 29 months, with recruitment having commenced on June 27, 2023, and the study expected to conclude by November 12, 2025.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment, 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. These visits are crucial for monitoring the participants' health, assessing the investigational product's effects, and collecting data on 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 safety and efficacy.
The expected length of participant involvement in the trial is contingent upon the individual's response to the treatment and the occurrence of any adverse events. Participants may be withdrawn from the study early if they experience significant adverse reactions, if the disease progresses, or if they choose to withdraw consent. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.
Treatment
The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.
Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.
Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.
Efficacy
The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date is June 27, 2023, with an anticipated end date of November 12, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary data on the intervention's effects. The trial will likely employ standardized methods for measuring and analyzing efficacy, which may include validated scales, laboratory tests, or other relevant instruments. The schedule for these assessments is not specified, but they are typically conducted at various timepoints throughout the trial to monitor changes and outcomes. The data collected will contribute to understanding the intervention's potential benefits and inform subsequent trial phases.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Belgium | Not Recruiting | 27 Jun 2023 | 84 |

