In short
Clinical trials are investigating ASP3082 in people with metastatic or locally advanced non-small-cell lung cancer and pancreatic ductal adenocarcinoma. These studies aim to evaluate how well the treatment works and to collect biomarker data that may help explain response or resistance. The main trial is in Phase 2 and includes adults with these cancers.
Key points
- Clinical trials are studying ASP3082 in people with metastatic or locally advanced non-small-cell lung cancer and pancreatic ductal adenocarcinoma. The main study is a Phase 2, multicenter, open-label trial. It is designed to evaluate efficacy and to collect biomarker data that may help explain response or resistance. The trial plans to enroll 60 participants. The main outcome is best overall response, measured by RECIST v.1.1. This research focuses on patients with these specific cancer types.
Trial overview
The available study is a Phase 2, multicenter, open-label trial of ASP3082 called UNLOCK ASP3082. It is an interventional study, which means participants receive a study treatment so researchers can measure its effect. The study is authorised and plans to enroll 60 people.
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). 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. These are the target populations for the study, so the research is focused on these two cancer types.
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. The study is multicenter, which means it is being run at more than one site. It is also open-label, meaning the treatment is known to the study team and the participants.
The listed interventions include ASP3082 given intravenously and a dextrose injection / BRADEX 5% given intravenously. The source data do not provide more detail on the study schedule or how the comparison is organized.
What the trial is measuring
The main outcome is best overall response (BOR), based on investigator assessment using RECIST v.1.1. Best overall response is the best tumor response seen during the study, such as shrinkage or improvement. RECIST v.1.1 is a standard method used in cancer trials to measure how tumors change on scans.
The brief summary says the purpose of the study is to evaluate the efficacy of ASP3082. Efficacy means how well a treatment works in the study setting.
Biomarker analysis and response
The trial also includes biomarker analysis to characterize response and resistance. Biomarker analysis means testing samples for signs that may help explain why a cancer responds or does not respond to treatment. Resistance means the cancer does not respond well to the study treatment.
This part of the study may help researchers understand which patients benefit most from ASP3082 and why some tumors may not respond as expected.
Key trial details
- Trial ID: 2025-522533-54-00.
- Trial name: UNLOCK ASP3082.
- Phase: Phase 2.
- Status: Authorised.
- Population: Patients with metastatic NSCLC and PDAC.
- Planned enrollment: 60 participants.
- Main endpoint: Best overall response by RECIST v.1.1.