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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

This study is recruiting at 10 US sites in 8 states, according to its ClinicalTrials.gov record last updated .

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, also known as imneskibart, 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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

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

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Aulos Bioscience, Inc.
Last updated on ClinicalTrials.gov
September 18, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 1

  • Sylvester Comprehensive Cancer Center - Miami · Miami, FL

Michigan · 1

  • START Midwest · Grand Rapids, MI

Minnesota · 1

  • Minnesota Oncology and Hematology PA · Minneapolis, MN

Missouri · 1

  • Washington University · St Louis, MO

North Carolina · 1

  • Carolina Biooncology Institute · Huntersville, NC

Tennessee · 1

  • Sarah Cannon Research Institute · Nashville, TN

Texas · 3

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

Utah · 1

  • University of Utah - Huntsman Cancer Institute · Salt Lake City, UT

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.