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
Patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received 2 or less prior lines of therapy excluding somatostatin analogs
the patient has been on a stable dose of an somatostatin analogs for ≥12 weeks and
the patient has experienced disease progression while on stable somatostatin analogs dose
Patients must have 1 or more measurable target lesions by RECIST v1.1
Prior treatment with mTOR inhibitors including nab-sirolimus
Patients with functional NETs who are experiencing uncontrolled symptoms attributed to hormones and other vasoactive substances secreted by the tumor
Patients with inactivating TSC1 or TSC2 alterations (based on tissue or liquid NGS)
Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment