OncoMatch/Clinical Trials/NCT05661461
Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment
Is NCT05661461 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies nab-sirolimus for tumor, solid.
Treatment: nab-sirolimus — This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: mTOR inhibitor
Received prior treatment with an mTOR inhibitor within 4 weeks prior to first dose
Lab requirements
Blood counts
ANC ≥1.0 × 10^9/L (growth factor support allowed); Platelet count ≥75,000/mm^3 (transfusion and/or growth factor support allowed); Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed)
Kidney function
Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation
Liver function
For normal hepatic function: total bilirubin ≤ ULN and AST ≤ ULN. For moderate hepatic impairment: total bilirubin 1.5-3.0 × ULN and any level of AST.
Adequate hematologic counts...Creatinine clearance ≥30 mL/min...Normal hepatic function (total bilirubin ≤ ULN and AST ≤ULN)...Moderate hepatic impairment (total bilirubin 1.5-3.0 × ULN and any level of AST)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- South Texas Accelerated Research Therapeutics, LLC · San Antonio, Texas
- START Mountain Region · West Valley City, Utah
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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