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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05267626

Run by

Aulos Bioscience, Inc.

People needed

159

Starts

2022-04-04

Expected to finish

2027-02-28

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Unhealed wounds from surgery or injury
• Treatment with > 10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within the 7 days prior to the initiation of study drug. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed
• Prior anti-cancer therapy before the planned start of AU-007 as follows:
• Not recovered to baseline from toxicity of prior systemic cancer therapy(ies).
• Not recovered from toxicity of radiotherapy.
• Concurrent use of hormones either to maintain castrate levels of testosterone in patients with castration-sensitive prostate cancer or for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) is acceptable. Bisphosphonates are permitted.
• Patients who have experienced serious adverse events during prior IL-2 therapy (including but not limited to bowel perforation, gastrointestinal bleeding, arrythmias, myocardial infarction, repetitive seizures).
• Inflammatory process that has not resolved for ≥ 4 weeks from the date of first study dose. Patients with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of duration
• Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required therapy, with the exception of indolent lymphomas

Where it is running

• Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Minnesota Oncology and Hematology PA — Minneapolis, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Atlantic Healthcare System — Morristown, New Jersey, United States (enrolling)
• Carolina Biooncology Institute — Huntersville, North Carolina, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Texas Oncology (Balcones) - SCRI — Austin, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• START South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (enrolling)
• University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• Southside Cancer Care Centre — Miranda, New South Wales, Australia (enrolling)
• Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia (enrolling)
• Monash Health — Clayton, Victoria, Australia (enrolling)
• Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia (enrolling)
• Austin Health — Heidelberg, Victoria, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Sunshine Hospital — Saint Albans, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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