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NCT05267626 · ClinicalTrials.gov registry record · Phase 1

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

A Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by Aulos Bioscience.

Recruiting
Registry status
Phase 1
Development phase
159
Enrollment target
17
Study locations

NCT05267626 is a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor that is actively recruiting participants, run by Aulos Bioscience. The registered enrollment target is 159 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (76% lower). The trial reports 17 study locations across 11 states.

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The verdict

NCT05267626, a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, is actively recruiting participants, sponsored by Aulos Bioscience.

RECRUITING
Registry status
Phase 1
Development phase
159 participants
Enrollment target
17
Study locations

Study Summary

This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.

Conditions Studied

Non-Small Cell Lung Cancer Advanced Solid Tumor Metastatic Cancer Cutaneous Melanoma

Interventions

  • DRUG Nivolumab
  • DRUG Aldesleukin
  • DRUG Avelumab
  • DRUG AU-007

Study Locations (17)

Victoria

  • Monash Health - Clayton
  • Peninsula & South Eastern Haematology and Oncology Group - Frankston
  • Austin Health - Heidelberg
  • The Alfred Hospital - Melbourne
  • Sunshine Hospital - Saint Albans

Texas

  • Texas Oncology (Balcones) - SCRI - Austin
  • MD Anderson Cancer Center - Houston
  • START South Texas Accelerated Research Therapeutics - San Antonio

Florida

  • Sylvester Comprehensive Cancer Center - Miami - Miami

Michigan

  • START Midwest - Grand Rapids

Minnesota

  • Minnesota Oncology and Hematology PA - Minneapolis

Missouri

  • Washington University - St Louis

North Carolina

  • Carolina Biooncology Institute - Huntersville

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2022-04-04
Est. Completion 2026-06-12
Phase Phase 1

Sponsor

Aulos Bioscience

1 total trials

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What the Registry Record Tells You About NCT05267626

The ClinicalTrials.gov registry entry for NCT05267626 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (76% lower). The listed sponsor is Aulos Bioscience, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.

NCT05267626 reports 17 study locations spanning 11 distinct geographic areas - top geographies include Victoria, Texas, Florida.

Frequently Asked Questions

What is clinical trial NCT05267626 about?

NCT05267626 is a clinical study titled "Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer". This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with ...

What is the current status of trial NCT05267626?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 159 participants. The study started on 2022-04-04. Estimated completion is 2026-06-12.

What conditions does trial NCT05267626 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma.

What interventions are being tested in trial NCT05267626?

The interventions under investigation include: Nivolumab (DRUG), Aldesleukin (DRUG), Avelumab (DRUG), AU-007 (DRUG).

Who is sponsoring clinical trial NCT05267626?

This trial is sponsored by Aulos Bioscience, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05267626 being conducted?

This trial has 17 study locations across Florida, Michigan, Minnesota, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.