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RECRUITING 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

NCT05267626 · View on ClinicalTrials.gov ↗

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.

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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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05267626

The ClinicalTrials.gov registry entry for NCT05267626 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 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aulos Bioscience, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions — of which Nivolumab 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: NCT05267626 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Victoria, Texas, Florida. 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 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: Advanced Solid Tumor, Non-Small Cell Lung Cancer, Metastatic Cancer, Cutaneous Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05267626?

The interventions under investigation include: Nivolumab (DRUG), Aldesleukin (DRUG), Avelumab (DRUG), AU-007 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05267626?

This trial is sponsored by Aulos Bioscience, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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