Actively Recruiting
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
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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: Absolute neutrophil count 61.0 �D7 109 /L (growth factor support allowed); Platelet count 6175,000/mm 3 (75 �D7 10 9 /L) (transfusion and/or growth factor support allowed); Hemoglobin 618.0 g/dL (transfusion and/or growth factor support allowed)
- Creatinine clearance 6530 mL/min as assessed by the Cockcroft-Gault equation
- Fasting serum triglyceride must be 64300 mg/dL; fasting serum cholesterol must be 64350 mg/dL
- Male or non-pregnant and non-breastfeeding female: females of child-bearing potential must agree to use highly effective contraception or abstinence from 28 days prior to first dose through 3 months after last dose with negative pregnancy tests; males must use condoms or abstain during sexual contact with females of childbearing potential and for 3 months after last dose
- Minimum of 4 weeks since major surgery, radiation, or systemic anticancer therapy with recovery to Grade 641 toxicity
- For patients with normal hepatic function: normal total bilirubin and AST levels
- For patients with moderate hepatic impairment: total bilirubin 1.5-3.0 �D7 upper limit of normal and any level of AST
You will not qualify if you...
- Prior treatment with an mTOR inhibitor within 4 weeks prior to first dose
- Severe or uncontrolled medical or psychiatric conditions affecting participation
- Meningeal carcinomatosis, symptomatic or unstable brain metastases, spinal cord compression, or untreated brain metastases (stable brain metastases allowed)
- Unstable angina, symptomatic congestive heart failure (NYHA class III or IV), recent myocardial infarction within 6 months, serious uncontrolled arrhythmia, or other significant cardiac disease
- Severely impaired lung function or pulmonary hypertension
- Uncontrolled hypertension (systolic 65160 mmHg or diastolic 65100 mmHg)
- History of interstitial lung disease or pneumonitis
- Known HIV infection
- Active Hepatitis B or C with detectable viral load
- Active severe infection requiring IV antibiotics
- Use of high-dose systemic corticosteroids (>10 mg prednisone or equivalent) within 2 weeks prior to first dose
- History of Gilbert's disease
- Any condition judged by the investigator to pose unacceptable risk or hinder participation
- For patients with moderate hepatic impairment: recent liver disease exacerbation within 2 weeks, clinically demonstrable tense ascites, recent acute viral hepatitis within 1 month, evidence of hepatorenal syndrome, presence of transjugular intrahepatic portosystemic shunt, or active stage 3 or 4 encephalopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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