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Nab-sirolimus for Neuroendocrine Tumors of the GI Tract, Lung, or Pancreas

This study is testing a drug called nab-sirolimus for people with well-differentiated neuroendocrine tumors (NETs) in the gastrointestinal (GI) tract, lung, or pancreas. These are tumors that have not spread widely or are locally advanced and cannot be removed by surgery. You may be able to join if you have received two or fewer prior treatments, excluding somatostatin analogs. The study aims to see how well nab-sirolimus works and if it is safe over 12 months. This drug works by targeting a pathway in the body called MTOR. The study is currently unclear about its recruitment status and plans to enroll 21 participants.

Study design
This is a Phase 2, single-arm, open-label study, meaning all participants will receive nab-sirolimus. It plans to enroll 21 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures the efficacy of nab-sirolimus at 12 months.

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

NCT05997056

Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors

Completed
PHASE2Ages 18+InterventionalTreatment
Aadi Bioscience, Inc.
~12 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:nab-sirolimus

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants With Objective Response Rate
Measured over From the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks (±7 days) for the first 12 weeks, and every 12 weeks (±7 days) thereafter, up to 22 months.

Conditions

Neuroendocrine Tumors
NET
Pancreatic Neuroendocrine Tumor
Gastrointestinal Neuroendocrine Tumor
Pulmonary Neuroendocrine Tumor

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Neuroendocrine Neoplasm

Where it's being run

4 sites across 4 states
California1
Colorado1
Texas1
Wisconsin1

Study leadership

  • Leonor Nazareno · STUDY_DIRECTOR · Aadi Bioscience

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Percentage of Participants With Objective Response RateFrom the start of study treatment to radiographically confirmed disease progression (PD) per RECIST v1.1, assessed at screening, every 6 weeks (±7 days) for the first 12 weeks, and every 12 weeks (±7 days) thereafter, up to 22 months.

    Objective Response Rate (ORR) is defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression (PD) is defined per RECIST v1.1 as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or the appearance of one or more new lesions.