Phase 12 Study of AU-007, an Antibody Targeting IL-2, Alone or with Aldesleukin and Other Immunotherapies in Advanced Unresectable or Metastatic Cancer

What this Trial Is About

Researchers are studying AU-007 imneskibart, a monoclonal antibody that binds to IL-2 and inhibits IL-2 receptor alpha binding, in patients with unresectable locally advanced or metastatic cancer. This open-label, first-in-human Phase 12 trial aims to evaluate the safety, tolerability, and initial effectiveness of AU-007 alone or combined with aldesleukin, a single loading dose of aldesleukin, or with aldesleukin plus checkpoint inhibitors avelumab or nivolumab. The study includes patients ineligible for or who have progressed on standard therapies. The trial has multiple parts dose escalation arms testing AU-007 alone and in combination with aldesleukin given every two weeks, followed by expansion cohorts focusing on selected cancers like cutaneous melanoma and non-small cell lung cancer NSCLC. Later parts assess AU-007 plus aldesleukin combined with avelumab or nivolumab. AU-007 and other study drugs are administered by intravenous infusion on schedules such as every two or four weeks, depending on the treatment arm. Participants will undergo regular safety assessments, blood tests to evaluate drug levels and immune responses, and tumor imaging to measure disease status. Researchers will monitor side effects and signs of anti-tumor activity from the first dose until 28 days after the last dose. The study includes ongoing evaluations of pharmacokinetics, immunogenicity, and cytokine changes. Total participation lasts until the end of treatment plus safety follow-up, with detailed monitoring throughout.

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