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Phase 1 nab-sirolimus for advanced solid tumors with liver impairment

This study is testing a drug called nab-sirolimus in adults with locally advanced or metastatic (spread to other parts of the body) solid tumors. It's a Phase 1 study, which means it's focused on finding a safe dose and understanding how the drug moves through the body, especially in patients who also have moderate liver problems. Researchers will be looking at the highest dose that can be safely given (MTD) and how much of the drug is in the blood over time. You may be able to join if you are at least 18 years old and have a confirmed solid tumor.

Study design
This is a Phase 1, multi-center, open-label (everyone knows what treatment is being given) study. It plans to enroll 28 adult participants.
What's involved
Participants will receive nab-sirolimus through an IV (intravenous) infusion over 30 minutes on Days 1 and 8 of each cycle.
Compensation
Not stated in the trial record.
Follow-up
The main safety measure (MTD) will be assessed through Day 22. Drug levels in the blood will be measured at the start and until the drug is no longer detectable.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Aadi Bioscience, Inc.
~28 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:nab-sirolimus

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD for patients with moderate hepatic impairment
Measured over Through Day 22
+3 more outcomes measured

Conditions

Tumor, Solid
Tumor
Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT05661461

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • START Mountain Region

    West Valley City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Aadi Medical Information
[email protected]
1-888-246-2234
Email the study team

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Eligibility criteria

Inclusion

For All Patients
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) 6. Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation:
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 test (urine or serum) result at screening and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.
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 dose. A second form of birth control is required even if he has undergone a successful vasectomy. 9. 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 either case adequately recovered from the acute toxicities of any prior therapy (including neuropathy) to Grade ≤1. For Patients with Normal Hepatic Function 10. Normal hepatic function (total bilirubin ≤ upper limit of normal \[ULN\] and aspartate aminotransferase \[AST\] ≤ULN). For Patients with Moderate Hepatic Impairment 11. Moderate hepatic impairment (total bilirubin 1.5-3.0 × ULN and any level of AST)

What this trial measures

  • MTD for patients with moderate hepatic impairmentThrough Day 22
  • Maximum concentration (Cmax)Time 0
  • Area under the serum concentration-time curveTime 0 to time of the last quantifiable concentration (AUC 0-last)
  • Area under the serum concentration-time curveTime 0 to 168 hours (AUC 0-168)