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Patients with well-differentiated neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.

Prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus administered by IV infusion

nab-sirolimus

Aadi Bioscience Medical Information

Jason Ledesma

Michael Demeure, MD

Jennifer Hedge

Allen Cohn, MD

Christine Terraciano

Scott Paulson, MD

Alexandria Phan, MD

Willis Navarro, MD

A Phase 2 multi-center, open-label, single arm study 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

This is a prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus and patients with functional or non-functional, well-differentiated, locally advanced unresectable in metastatic NETs of the GI tract, lung, or pancreas.

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

A Phase 2 Multi-center, Open-label, Single Arm Study 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

Objective Response Rate (ORR), defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using RECIST v1.1

Incidence and severity of treatment-emergent and treatment-related adverse events (AEs) as assessed by NCI CTCAE v5.0

Determined for patients with BOR of confirmed CR or PR defined as time from scan first showing response by RECIST v1.1 to PD or death

BOR of confirmed CR or PR (either of any duration) or stable disease (SD) ≥12 weeks by RECISTv1.1 following study treatment initiation

Time from first dose of study medication to initial measurement of CR or PR, where CR or PR is subsequently confirmed by RECIST v1.1

Number of months from study treatment initiation to the date of disease progression or death due to any cause

Number of months from study treatment initiation to the date of death due to any cause

Aadi Bioscience, Inc.

Spots Global Cancer Trial Database for pulmonary neuroendocrine tumor