In short
Clinical trials investigating Imsidolimab are studying whether it is safe and effective in people with advanced solid tumors, lymphomas, and metastatic non-small cell lung cancer. The trials are looking at dose safety, tolerability, and signs of tumor response in specific patient groups. These studies are in early phases and include adults with advanced cancer.
Key points
- Clinical trials investigating Imsidolimab are early-stage studies in adults with advanced cancer. The provided trial includes people with advanced solid tumors or lymphomas, and some parts focus on HLA-A2 positive patients with metastatic non small cell lung cancer. The study is a Phase 1/2 trial, so it first looks at safety, tolerability, and dose selection, then early signs of benefit. Key endpoints include dose limiting toxicity, maximum tolerated dose, recommended Phase 2 dose, and overall tumor response. The trial is authorised and plans to enroll 70 participants. Some parts compare Imsidolimab-based treatment with another study drug combination in first-line metastatic NSCLC.
Clinical trial overview
The available trial record shows a Phase 1/2 study of Imsidolimab in people with cancer. The study is listed as authorised and plans to enroll 70 participants.
The trial title describes the study as a multicenter trial, which means it is run at more than one hospital or research site. It is an interventional study, so participants receive study treatment rather than only being observed.
Who the trials are for
Part A includes patients with advanced solid tumors or lymphomas. This means the study is open to adults with cancers that are already advanced and no longer limited to one place in the body.
Parts B and C focus on patients with HLA-A2 positive phenotype and metastatic non small cell lung cancer. HLA-A2 positive means a person must have a specific marker to join those parts of the study.
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.
Trial phase and study design
This is a Phase 1/2 trial, so it combines early safety testing with early activity testing. 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.
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. 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.
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.
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. Part A uses these data to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D).
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. This helps the researchers watch closely for early safety problems after treatment starts.
For Part C, the main outcome is overall response rate (ORR), including complete response (CR) and partial response (PR). These are standard ways to measure whether tumors shrink or disappear during treatment.
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. This part is designed to help choose the best dose for later testing.
Part B looks at the combination of OSE-279 and OSE2101 to see whether it is safe and tolerable. Tolerability means how well people can stay on treatment without side effects becoming too difficult.
Part C compares the antitumor activity of the combination against OSE-279 alone in first-line metastatic stage IV NSCLC. The goal is to see whether the combination leads to better tumor responses.
Key patient-friendly terms
Intravenous infusion means a treatment is given through a vein. Subcutaneous injection means a shot given under the skin.
Metastatic means the cancer has spread to other parts of the body. Stage IV is a common way to describe advanced cancer that has spread.
Safety and tolerability are important early trial goals because they show whether the treatment can be given without too many serious problems. Antitumor activity means signs that the treatment may help shrink or control the cancer.