Table of contents
- Trial overview
- Who is being studied
- Study design and phase
- What the trial is measuring
- Biomarker analysis and response
- Key trial details
Trial overview
The available study is a Phase 2, multicenter, open-label trial of ASP3082 called UNLOCK ASP3082.[1] It is an interventional study, which means participants receive a study treatment so researchers can measure its effect.[1] The study is authorised and plans to enroll 60 people.[1]
Who is being studied
The trial is designed for patients with metastatic non-small-cell lung cancer (NSCLC) and patients with pancreatic ductal adenocarcinoma (PDAC).[1] Metastatic means the cancer has spread to other parts of the body, and locally advanced means it has grown more widely in the nearby area.[1] These are the target populations for the study, so the research is focused on these two cancer types.[1]
Study design and phase
This is a Phase 2 study, so it is meant to look more closely at whether ASP3082 may help people with these cancers.[1] The study is multicenter, which means it is being run at more than one site.[1] It is also open-label, meaning the treatment is known to the study team and the participants.[1]
The listed interventions include ASP3082 given intravenously and a dextrose injection / BRADEX 5% given intravenously.[1] The source data do not provide more detail on the study schedule or how the comparison is organized.[1]
What the trial is measuring
The main outcome is best overall response (BOR), based on investigator assessment using RECIST v.1.1.[1] Best overall response is the best tumor response seen during the study, such as shrinkage or improvement.[1] RECIST v.1.1 is a standard method used in cancer trials to measure how tumors change on scans.[1]
The brief summary says the purpose of the study is to evaluate the efficacy of ASP3082.[1] Efficacy means how well a treatment works in the study setting.[1]
Biomarker analysis and response
The trial also includes biomarker analysis to characterize response and resistance.[1] Biomarker analysis means testing samples for signs that may help explain why a cancer responds or does not respond to treatment.[1] Resistance means the cancer does not respond well to the study treatment.[1]
This part of the study may help researchers understand which patients benefit most from ASP3082 and why some tumors may not respond as expected.[1]
