Skip to content
Study details
Enrolling now

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

Aulos Bioscience, Inc.
NCT IDNCT05267626ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

159

Study length

about 4.2 years

Ages

18+

Locations

11 sites in FL, MI, MN +6

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take AU-007
  • 2.Take Aldesleukin
  • 3.Take Avelumab
  • +1 more
PhasePhase 1/Phase 2
DrugAldesleukin
Primary goalEstablish the maximum tolerated dose (MTD) and/or RP2D

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low7%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

aldesleukin, avelumab, nivolumab (Immune checkpoint inhibitor; blocks PD-1 receptor on T cells)

Drug routes

injection, intravenous, infusion

Endpoints

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

Body systems

Oncology