RecruitingAdvanced Solid TumorMetastatic CancerCutaneous Melanoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: Aulos Bioscience, Inc.

You may not qualify if…

✕ Patients with a history of known autoimmune disease with exceptions of
✕ Vitiligo
✕ Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment
✕ History of Graves' disease in patients now euthyroid for \> 4 weeks
✕ Hypothyroidism managed by thyroid hormone replacement
✕ Alopecia
✕ Arthritis managed without systemic therapy beyond oral nonsteroidal anti- inflammatory drugs
✕ Major surgery or traumatic injury within 3 weeks before first dose of AU-007