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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by Aulos Bioscience.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (76% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured by the frequency of DLTs (Dose limiting toxicity) and safety profile
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2026-06-12 |
| Phase | Phase 1 |
What NCT05267626 shows while recruiting
NCT05267626 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (76% lower).
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 lists 17 locations in 11 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05267626's enrollment target sits among peer trials
159 194th of 454 higher than 261 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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