NCT05267626 · Aulos Bioscience, Inc.
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
What this study is about
This is a first in human, where both patients and doctors know the treatment given, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial effectiveness of AU-007 in patients with advanced solid tumors.
View original scientific description
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).
Interventions
DRUG
AU-007
Monoclonal Antibody Targeting IL-2
DRUG
Aldesleukin
IL-2
DRUG
Avelumab
Monoclonal Antibody Targeting PD-L1
DRUG
Nivolumab
Monoclonal Antibody Targeting PD-1
Primary outcome measures
Evaluate the safety and tolerability of AU-007
Time frame: Day 1 thru end of treatment (EOT) visit (28 days after last dose)
Measured by the frequency of DLTs (Dose limiting toxicity) and safety profile
Establish the maximum tolerated dose (MTD) and/or RP2D
Time frame: Day 1 thru EOT visit (28 days after last dose)
With AU-007 alone or in combination with aldesleukin measured by pharmacokinetics (PK), pharmacodynamics (PD), and Biomarkers
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI
- Part 2 includes but is not limited to:
- Cutaneous melanoma that is either locally unresectable or metastatic:
- BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4
- BRAF mutation: patients who refused BRAF+MEK inhibitor
- Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3)
- Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)
- LDH ≤ 2.5 x ULN
- NSCLC: Unresectable locally advanced or metastatic PD-L1-positive (tumor proportion score \[TPS\] ≥ 1%) NSCLC not harboring a
Where
- Miami, Florida
- Grand Rapids, Michigan
- Minneapolis, Minnesota
- St Louis, Missouri
- Morristown, New Jersey
- Huntersville, North Carolina
- Nashville, Tennessee
- Austin, Texas
- Houston, Texas
- San Antonio, Texas
- Salt Lake City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations