Phase 2 Study of Nab-sirolimus Infusion for Treatment of Well-differentiated Neuroendocrine Tumors of the Gastrointestinal Tract, Lung, or Pancreas Without Prior mTOR Inhibitor Therapy

What this Trial Is About

Researchers are evaluating the effectiveness and safety of nab-sirolimus in adults with well-differentiated neuroendocrine tumors NETs located in the gastrointestinal tract, lung, or pancreas who have not previously been treated with mTOR inhibitors. This phase 2, open-label, single-arm study focuses on patients with either functional or non-functional, locally advanced unresectable or metastatic NETs. The study aims to provide important information on how nab-sirolimus works in this specific patient group. Participants will receive nab-sirolimus administered through intravenous infusion during the study. This is a single-arm trial, meaning all participants receive the study drug without comparison to a placebo or other treatment. The study is multi-center and open-label, so both researchers and participants know the treatment being given. There are no separate study groups or placebo arms. Throughout the 12-month study period, participants will have regular visits for assessments including measuring the tumor response using RECIST criteria, monitoring treatment safety and side effects, and evaluating disease control and progression-free survival. Overall survival will also be followed for up to 24 months. Participants will undergo scheduled laboratory tests, imaging, and physical examinations to track health status and treatment effects. The study includes careful monitoring to ensure participant safety and treatment adherence.

Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors