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Tests treatment safety and results for Tumor, Solid
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
ClinicalTrials.gov ID: NCT05661461
What this study is testing
What is nab-sirolimus?
nab-sirolimus is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tumor, solid.
Also referred to as ABI-009, nab-rapamycin, albumin-bound rapamycin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For All Patients
- 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.
You likely can't join if
- Received prior treatment with an mTOR inhibitor within 4 weeks prior to first dose.
- Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation...
- Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, untreated brain metastases or symptomatic or unstable...
- Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association, NYHA class III or IV), myocardial infarction ≤6 months...
- Pre-existing severely impaired lung function. If a patient has a pre-existing pulmonary condition, eligible patients should have a spirometry and...
- Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy. Note, controlled...
See the full eligibility criteria
- For All Patients
- 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 (ANC) ≥1.0 × 109 /L (growth factor support allowed)
- Platelet count ≥75,000/mm 3 (75 × 10 9 /L) (transfusion and/or growth factor support allowed)
- Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed)
- Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation: Creatinine Clearance ≥30 = (140 - age) × (weight[kg] / (72 x SCr[mL/min]\_ x 0.85, if female
- Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be ≤350 mg/dL.
- Male or non-pregnant and non-breastfeeding female:
- Females of child-bearing potential must agree to use highly effective contraception or abstinence without interruption from 28 days prior to first dose throughout 3 months after last dose and have a negative pregnancy...
- Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and throughout 3 months after last...
- Minimum of 4 weeks since major surgery, completion of radiation, or completion of all prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and in...
- Normal hepatic function (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] ≤ULN). For Patients with Moderate Hepatic Impairment
- Moderate hepatic impairment (total bilirubin 1.5-3.0 × ULN and any level of AST)
- Received prior treatment with an mTOR inhibitor within 4 weeks prior to first dose.
- Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
- Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, untreated brain metastases or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases...
- Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association, NYHA class III or IV), myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia...
- Pre-existing severely impaired lung function. If a patient has a pre-existing pulmonary condition, eligible patients should have a spirometry and diffusing capacity for carbon monoxide (DLCO) that is \>50% of the normal...
- Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy. Note, controlled non melanoma skin cancers, carcinoma in situ of the cervix, resected...
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).
- Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
- Individuals with known human immunodeficiency virus (HIV) infection are excluded from this study as combination antiretroviral therapy could potentially result in significant pharmacokinetic interactions. In addition...
- Active Hepatitis B or Hepatitis C, with detectable viral load. Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients.
- Have active severe (Grade ≥3) infection requiring intravenous (IV) antibiotics (contact medical monitor for clarification).
- High-dose systemic corticosteroids (\>10 mg of prednisone or its equivalent) are not permitted within 2 weeks of first dose. However, inhaled, intranasal, intra articular, and topical steroids are allowed.
- Have a history of Gilbert's disease.
- Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures. For Patients with Moderate...
- Had a clinical exacerbation of liver disease within the 2-week period prior to first dose (ie, abdominal pain, nausea, vomiting, anorexia, or fever).
- Have clinically demonstrable, tense ascites.
- Had evidence of acute viral hepatitis within 1 month prior to first dose.
- Have evidence of hepatorenal syndrome.
- Have a transjugular intrahepatic portosystemic shunt.
- Have active stage 3 or 4 encephalopathy.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
- West Valley City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States; West Valley City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.