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 (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT05661461 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mTOR inhibitor disqualifies patients from enrollment.
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 qualify