Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05661461 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Advanced Solid Tumor and Tumor, sponsored by Aadi Bioscience.

Recruiting
Registry status
Phase 1
Development phase
28
Enrollment target
2
Study locations

NCT05661461: Recruiting Phase 1 study of Advanced Solid Tumor and Tumor, sponsored by Aadi Bioscience.

NCT05661461 is a Phase 1 study of Advanced Solid Tumor and Tumor that is actively recruiting participants, run by Aadi Bioscience. The registered enrollment target is 28 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05661461, a Phase 1 study of Advanced Solid Tumor and Tumor, is actively recruiting participants, sponsored by Aadi Bioscience.

RECRUITING
Registry status
Phase 1
Development phase
28 participants
Enrollment target
2
Study locations

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
Aadi Bioscience

9 total trials

What NCT05661461 shows while recruiting

NCT05661461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (85% lower).

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.

NCT05661461 reports a single indexed study location in Texas, Utah.

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.

What interventions are being tested in trial NCT05661461?

The interventions under investigation include: nab-sirolimus (DRUG).

Who is sponsoring clinical trial NCT05661461?

This trial is sponsored by Aadi Bioscience, which has 9 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05661461's enrollment target sits among peer trials

28 178th of 189 higher than 11 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03471117 · 28 participants · Phase 4

    Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients

  • NCT03523975 · 28 participants · Phase 1

    Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

  • NCT03608631 · 28 participants · Phase 1

    iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation

  • NCT03810651 · 28 participants · Early Phase 1

    Pencil Beam Scanning in Patients With Renal Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05661461, the US trial registry maintained by the National Library of Medicine. NCT05661461 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.