Evaluation of [Main Substance] in Combination with Other Agents in Patients with Advanced Solid Tumors
- Trial ID
- 2024-515020-36-00
- Sponsor
- Corbus Pharmaceuticals Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this clinical trial is to evaluate the efficacy and safety of investigational treatments in patients with **advanced solid tumors**. This is clinically relevant as it aims to address the therapeutic needs of patients with limited treatment options due to the advanced stage of their disease. The study seeks to provide insights into potential new therapies that could improve patient outcomes in this challenging clinical context.
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 18 to 65 years. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on criteria that are not detailed in the available data. There are no specific lifestyle considerations such as diet, physical activity, or habits mentioned for this trial. The sponsor has not disclosed key inclusion or exclusion criteria.
Plans and Procedures
The clinical trial is designed to evaluate the efficacy and safety of an investigational treatment in patients with **advanced solid tumors**. The study is structured as a randomized, double-blind, controlled trial, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The trial is anticipated to commence recruitment on November 26, 2024, and is projected to conclude by September 30, 2026, encompassing a total duration of approximately 22 months.
Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit is crucial for determining the suitability of participants for the trial based on predefined inclusion and exclusion criteria. Following successful screening, participants will be randomized into treatment groups and will attend regular follow-up visits. These visits are scheduled to monitor the participants' health status, assess treatment efficacy, and record any adverse events. The frequency and number of follow-up visits will be determined by the study protocol. The trial will culminate in an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the treatment.
The expected length of participant involvement in the trial will vary depending on individual response to treatment and adherence to the study protocol. Participants may be withdrawn from the study prematurely if they experience significant adverse effects, fail to comply with study procedures, or if the investigator deems it necessary for their safety. The trial is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the protection and well-being of all participants throughout the study duration.
Treatment
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 treatment. 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.
Efficacy
No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information such as the parameters or endpoints used to evaluate efficacy, the methods and schedule for measuring, collecting, and analyzing these efficacy parameters, and any tools or instruments involved in efficacy assessments are not included. The trial is estimated to have a recruitment start date of November 26, 2024, and an estimated end date of September 30, 2026. The trial is categorized under phase 9, but further specifics on efficacy assessment are not available.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
France | Recruiting | 26 Nov 2024 | 32 |
Italy | Recruiting | 26 Nov 2024 | 32 |
Romania | Recruiting | 26 Nov 2024 | 32 |
Spain | Recruiting | 26 Nov 2024 | 32 |




