OncoMatch/Clinical Trials/NCT05997056
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
Is NCT05997056 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies nab-sirolimus for neuroendocrine tumors.
Treatment: nab-sirolimus — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Neuroendocrine Tumor
Pancreatic Cancer
Biomarker criteria
Excluded: TSC1 inactivating alteration
Excluded: TSC2 inactivating alteration
Performance status
ECOG OR KARNOFSKY 0–1
Prior therapy
Cannot have received: mtor inhibitor (nab-sirolimus)
Lab requirements
Blood counts
ANC ≥1.0 × 10^9/L (growth factor support allowed); Platelet count ≥100,000/mm^3 (transfusion/growth factor support allowed); Hemoglobin ≥8.0 g/dL (transfusion/growth factor support allowed)
Kidney function
creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or attributable to liver metastases, then ≤3 × ULN); AST and ALT ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)
Adequate liver function: Total bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or attributable to liver metastases, then ≤3 × ULN); AST and ALT ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases). Adequate renal function: creatinine clearance ≥30 mL/min. Adequate hematologic parameters: ANC ≥1.0 × 10^9/L; Platelet count ≥100,000/mm^3; Hemoglobin ≥8.0 g/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Rocky Mountain Cancer Centers · Denver, Colorado
- Texas Oncology · Dallas, Texas
- Medical College of Wisconsin Cancer Center · Milwaukee, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05997056 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mtor inhibitor disqualifies patients from enrollment.
Are patients with TSC1 alterations eligible?
No. TSC1 inactivating alteration is an exclusion criterion.
Are patients with TSC2 alterations eligible?
No. TSC2 inactivating alteration is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages