Table of Contents
- Clinical trial overview
- Who the trials are for
- Trial phase and study design
- What the trials measure
- Treatment parts and comparison groups
- Key patient-friendly terms
Clinical trial overview
The available trial record shows a Phase 1/2 study of Imsidolimab in people with cancer.[1] The study is listed as authorised and plans to enroll 70 participants.[1]
The trial title describes the study as a multicenter trial, which means it is run at more than one hospital or research site.[1] It is an interventional study, so participants receive study treatment rather than only being observed.[1]
Who the trials are for
Part A includes patients with advanced solid tumors or lymphomas.[1] This means the study is open to adults with cancers that are already advanced and no longer limited to one place in the body.[1]
Parts B and C focus on patients with HLA-A2 positive phenotype and metastatic non small cell lung cancer.[1] HLA-A2 positive means a person must have a specific marker to join those parts of the study.[1]
The brief summary also says Part C studies people with first-line metastatic stage IV NSCLC, which means the cancer has spread and this is the first treatment approach being tested in that setting.[1]
Trial phase and study design
This is a Phase 1/2 trial, so it combines early safety testing with early activity testing.[1] In Phase 1 parts, the main goal is usually to find a dose that people can tolerate, and in Phase 2 parts, the study looks more closely at whether the treatment may help the cancer.[1]
Part A studies Imsidolimab given as a single intravenous infusion every 3 or 6 weeks, while the trial record also lists TEDOPI as a subcutaneous injection in the intervention list.[1] The source data also names OSE-279 and OSE2101 in the summary and outcomes, so the study record appears to use these names in different parts of the trial description.[1]
Part B evaluates the safety and tolerability of the combination treatment, and Part C compares antitumor activity between a combination approach and OSE-279 alone.[1]
What the trials measure
The main endpoint in Part A is dose limiting toxicity (DLT), which means serious side effects that help researchers decide the best dose.[1] Part A uses these data to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).[1]
For Part B, the trial again measures DLT, and the DLT observation period is the first 6 weeks after the first injections of OSE-279 and OSE2101.[1] This helps the researchers watch closely for early safety problems after treatment starts.[1]
For Part C, the main outcome is overall response rate (ORR), including complete response (CR) and partial response (PR).[1] These are standard ways to measure whether tumors shrink or disappear during treatment.[1]
Treatment parts and comparison groups
Part A focuses on dose finding, with Imsidolimab given alone as a single intravenous infusion on every 3 or 6 weeks according to the brief summary.[1] This part is designed to help choose the best dose for later testing.[1]
Part B looks at the combination of OSE-279 and OSE2101 to see whether it is safe and tolerable.[1] Tolerability means how well people can stay on treatment without side effects becoming too difficult.[1]
Part C compares the antitumor activity of the combination against OSE-279 alone in first-line metastatic stage IV NSCLC.[1] The goal is to see whether the combination leads to better tumor responses.[1]
Key patient-friendly terms
Intravenous infusion means a treatment is given through a vein.[1] Subcutaneous injection means a shot given under the skin.[1]
Metastatic means the cancer has spread to other parts of the body.[1] Stage IV is a common way to describe advanced cancer that has spread.[1]
Safety and tolerability are important early trial goals because they show whether the treatment can be given without too many serious problems.[1] Antitumor activity means signs that the treatment may help shrink or control the cancer.[1]
