Table of contents
- Trial overview
- Who can join
- What is being measured
- Trial phase and design
- What the status means
- Related study details in the provided data
Trial overview
The trial data provided describes an interventional study, which means researchers give a study treatment and then observe what happens.[1] The study is authorized and is planned for 275 participants.[1] It is listed for people with solid tumors, which are cancers that form a mass in tissue or an organ.[1]
The source data also lists IMA401 among the interventions in the trial record.[1] The main study title in the provided record is for IMA402, but the intervention list includes IMA401, so the article focuses only on the trial information that is actually provided.[1]
Who can join
The target population is patients with recurrent and/or refractory solid tumors.[1] Recurrent means the cancer has come back after treatment, and refractory means the cancer is not responding well to treatment.[1]
This tells us the study is meant for people with advanced cancer situations where standard treatment has not worked well enough or the disease has returned.[1] The data does not give more detailed entry rules, so no other eligibility points can be confirmed from the source.[1]
What is being measured
The main goals are to study safety, tolerability, and anti-tumor activity.[1] Safety means how well the treatment can be given without causing harmful problems, while tolerability means how manageable the treatment is for patients.[1]
The primary outcomes include dose-limiting toxicities, which are side effects serious enough to limit the dose that can be given.[1] The study also tracks treatment-emergent adverse events and serious treatment-emergent adverse events, which are health problems that start or get worse after treatment begins.[1]
Researchers also measure how often treatment must be interrupted, reduced, or stopped permanently because of side effects.[1] In Phase II, they measure objective response rate, which is the number of patients whose tumors have a clear complete or partial response based on RECIST 1.1, a standard way to measure tumor change.[1]
Trial phase and design
The study is a Phase 1/2 trial.[1] Phase 1 studies usually focus on safety and finding the best dose range, while Phase 2 studies look more closely at whether the treatment may help the cancer.[1]
The brief summary in the source says the study aims to determine the maximum tolerated doses and/or recommended doses for extensions in Phase Ia, and then to further characterize safety and anti-tumor activity in later parts of the trial.[1] The trial also includes use of IMA402 alone or in combination with pembrolizumab in the title and brief summary, but the source data provided here does not give more detail about IMA401-specific treatment parts.[1]
What the status means
The study status is Authorised.[1] This means the trial has received permission to proceed according to the source record.[1]
The enrollment number is 275, which is the planned number of participants in the study.[1] This number helps show the size of the trial and how many people researchers expect to include.[1]
Related study details in the provided data
The trial title in the source is for IMA402, a bispecific T cell-engaging receptor molecule targeting PRAME, but the intervention list also includes IMA401.[1] Because the request is about IMA401, this article uses only the trial facts that are clearly present in the source data and does not add any extra details that are not stated.[1]
The brief summary states the study is looking at monotherapy and combination use, but the provided record does not separate which parts apply specifically to IMA401.[1] For that reason, the most reliable description is that IMA401 appears in the intervention list of an authorised Phase 1/2 study in solid tumors.[1]
