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
Phase 1/2
159
about 4.2 years
18+
11 sites in FL, MI, MN +6
What this study is about
This trial is testing a treatment called AU-007 in people with advanced solid tumors. AU-007 will be given alone, or with aldesleukin, or both AU-007 and aldesleukin every two weeks. Once the right dose of AU-007 plus aldesleukin is found, it will also be given with avelumab or nivolumab.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take AU-007
- 2.Take Aldesleukin
- 3.Take Avelumab
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
aldesleukin, avelumab, nivolumab (Immune checkpoint inhibitor; blocks PD-1 receptor on T cells)
injection, intravenous, infusion
Primary: Establish the maximum tolerated dose (MTD) and/or RP2D, Evaluate the safety and tolerability of AU-007
Secondary: Magnitude of PK changes in the blood after dosing determined by Half-life (T1/2) of AU-007, Magnitude of PK changes in the blood after dosing determined by area under the curve (AUC) of AU-007, Magnitude of PK changes in the blood after dosing determined by maximum concentration (Cmax) of AU-007, Magnitude of PK changes in the blood after dosing determined by time of maximum concentration (Tmax), Magnitude of cytokine changes in the blood after dosing
Oncology