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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 (May 2026). This Phase 2 trial studies nab-sirolimus for neuroendocrine tumors.

Phase 2RecruitingAadi Bioscience, Inc.NCT05997056Data as of May 2026

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

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Extracted eligibility criteria

Cancer type

Neuroendocrine Tumor

Biomarker criteria

Excluded: TSC1 inactivating alteration

Excluded: TSC2 inactivating alteration

Performance status

ECOG OR KARNOFSKY 0–1

Prior therapy

Max 2 prior lines

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 →

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