Actively Recruiting
A Phase 1, Open-label, Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment
Led by Aadi Bioscience, Inc. · Updated on 2025-11-13
28
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating nab-sirolimus in adults with locally advanced or metastatic solid tumors who have either moderate liver impairment or normal liver function. This phase 1, multi-center, open-label study focuses on understanding the safety and how the drug behaves in the body through a dose-escalation approach. The study is sponsored by Aadi Bioscience, Inc. and aims to gather important information to guide future treatments for these patients. Participants will receive nab-sirolimus through an intravenous infusion lasting about 30 minutes on Days 1 and 8. The study includes a dose-escalation period to determine the maximum tolerated dose for patients with moderate liver impairment. The treatment is given in a controlled setting to monitor the effects closely. Throughout the study, participants will undergo various assessments including blood tests to measure drug concentration and liver function, as well as monitoring for side effects. Key outcomes measured include maximum drug levels in the blood, how long the drug stays in the body, and overall safety up to Day 22. The study involves careful observation to understand how the treatment is processed in patients with different liver functions, with participation lasting according to the dosing and follow-up schedule.
CONDITIONS
Brief Title
Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent and comply with protocol requirements for the duration of the study
- Male or female patients at least 18 years of age at the time of signing the informed consent form
- Histologically confirmed locally advanced or metastatic solid tumors that is measurable or non-measurable
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Adequate hematologic counts including absolute neutrophil count 1.0 � 109/L, platelet count 75,000/mm3, and hemoglobin 8.0 g/dL
- Creatinine clearance 30 mL/min as assessed by Cockcroft-Gault equation
- Fasting serum triglyceride 300 mg/dL and cholesterol 350 mg/dL
- Male or non-pregnant and non-breastfeeding female with contraception requirements
- Minimum of 4 weeks since major surgery, radiation, or systemic anticancer therapy with recovery from acute toxicities
- For patients with normal hepatic function: total bilirubin upper limit of normal (ULN) and AST ULN
- For patients with moderate hepatic impairment: total bilirubin 1.5-3.0 � ULN and any level of AST
You will not qualify if you...
- Prior treatment with an mTOR inhibitor within 4 weeks before first dose
- Severe or uncontrolled medical or psychiatric conditions affecting participation
- Meningeal carcinomatosis, untreated or unstable brain metastases, or symptomatic brain metastases
- Unstable angina, symptomatic congestive heart failure (NYHA class III or IV), recent myocardial infarction within 6 months, serious uncontrolled cardiac arrhythmia
- Severely impaired lung function or oxygen saturation 88% at rest on room air
- Uncontrolled hypertension (systolic 160 mmHg or diastolic 100 mmHg)
- History of interstitial lung disease, pneumonitis, or pulmonary hypertension
- Known HIV infection
- Active Hepatitis B or C with detectable viral load
- Active severe infection requiring IV antibiotics
- Recent use of high-dose systemic corticosteroids
- History of Gilbert's disease
- Conditions placing patient at unacceptable risk or unlikely to comply
- For moderate hepatic impairment: recent liver disease exacerbation, tense ascites, acute viral hepatitis within 1 month, hepatorenal syndrome, transjugular intrahepatic portosystemic shunt, active stage 3 or 4 encephalopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 22 days
Participants receive nab-sirolimus by intravenous infusion over 30 minutes on Days 1 and 8 as part of a dose-escalation study to assess safety and pharmacokinetics.
2 infusion visits (in-person)
Trial Site Locations
Total: 2 locations
1
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
2
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
A
Aadi Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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