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RECRUITING Phase 1

Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment

NCT05661461 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG nab-sirolimus

Study Locations (2)

Texas

  • South Texas Accelerated Research Therapeutics, LLC — San Antonio

Utah

  • START Mountain Region — West Valley City

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2022-11-23
Est. Completion 2026-08-01
Phase Phase 1

Sponsor

Aadi Bioscience

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05661461

The ClinicalTrials.gov registry entry for NCT05661461 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aadi Bioscience, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which nab-sirolimus is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05661461 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Texas, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05661461 about?

NCT05661461 is a clinical study titled "Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment". 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.

What is the current status of trial NCT05661461?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2022-11-23. Estimated completion is 2026-08-01.

What conditions does trial NCT05661461 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Tumor, Tumor, Solid. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05661461?

The interventions under investigation include: nab-sirolimus (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05661461?

This trial is sponsored by Aadi Bioscience, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05661461 being conducted?

This trial has 2 study locations across Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial