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NCT05267626 · ClinicalTrials.gov record · last posted 2026-07-30

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

StatusRecruiting
PhasePhase 1/2
Started2022-04-04
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-07-31
Primary completion pushed: 2026-06-12 → 2027-02-28
2026-07-31
Completion pushed: 2026-06-12 → 2027-02-28
Trial Details
NCT Number NCT05267626
Lead Sponsor Aulos Bioscience, Inc.
Conditions Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer
Enrollment 159 participants
Start Date 2022-04-04
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-30