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, also known as imneskibart, 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

Trial Details

NCT ID
NCT05267626
Phase
PHASE1 / PHASE2
Sponsor
Aulos Bioscience, Inc.
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • AU-007
  • Aldesleukin
  • Avelumab
  • Nivolumab
Locations (sample)
  • Miami, Florida, United States|25.77427,-80.19366
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • Minneapolis, Minnesota, United States|44.97997,-93.26384
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Morristown, New Jersey, United States|40.79677,-74.48154

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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