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
Public ClinicalTrials.gov record NCT05267626. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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). 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.
Study identification
- NCT ID
- NCT05267626
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 159 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 3, 2022
- Primary completion
- Feb 27, 2027
- Completion
- Feb 27, 2027
- Last update posted
- Jul 29, 2026
2022 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136-1002 | Recruiting |
| START Midwest | Grand Rapids | Michigan | 49503-2563 | Recruiting |
| Minnesota Oncology and Hematology PA | Minneapolis | Minnesota | 55404-4526 | Recruiting |
| Washington University | St Louis | Missouri | 63110-1010 | Recruiting |
| Atlantic Healthcare System | Morristown | New Jersey | 07960 | Recruiting |
| Carolina Biooncology Institute | Huntersville | North Carolina | 28078 | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203-1619 | Recruiting |
| Texas Oncology (Balcones) - SCRI | Austin | Texas | 78731-4214 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030-4000 | Recruiting |
| START South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | Recruiting |
| University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05267626, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05267626 live on ClinicalTrials.gov.