Actively Recruiting
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
Led by Aulos Bioscience, Inc. · Updated on 2026-03-31
159
Participants Needed
18
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have measurable disease as confirmed by CT or MRI using RECIST v1.1 criteria
- Patients with cutaneous melanoma locally unresectable or metastatic meeting specified progression criteria
- Patients with unresectable locally advanced or metastatic PD-L1-positive NSCLC without EGFR mutation or ALK rearrangement and progression after anti-PD therapy
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before treatment
- Female patients of childbearing potential must use two forms of contraception from screening through 60 days after last dose (or 5 months for nivolumab recipients)
- Male patients with partners of childbearing potential must use barrier contraception from consent through 60 days after treatment and ensure partners use contraception
- Patients must have resolved immune-related toxicity from prior checkpoint inhibitor therapy to Grade 1 or baseline
- Patients with treated, asymptomatic CNS metastases stable for at least 14 days without current treatment or corticosteroids
You will not qualify if you...
- History of autoimmune disease requiring systemic treatment, with exceptions such as vitiligo, psoriasis, Graves' disease now euthyroid, hypothyroidism on hormone replacement, alopecia, or arthritis controlled without systemic therapy
- Major surgery or traumatic injury within 3 weeks before first AU-007 dose
- Unhealed wounds from surgery or injury
- Use of more than 10 mg prednisone daily or other immune-suppressive drugs within 7 days before treatment, except topical or inhaled steroids
- Not recovered from toxicity of prior cancer therapies or radiotherapy
- Serious adverse events from prior IL-2 therapy including bowel perforation, bleeding, arrhythmias, myocardial infarction, or seizures
- Unresolved inflammatory processes lasting 4 weeks or more
- Second primary invasive malignancy not in remission for at least 1 year, except some specified indolent cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136-1002
Actively Recruiting
2
START Midwest
Grand Rapids, Michigan, United States, 49503-2563
Actively Recruiting
3
Minnesota Oncology and Hematology PA
Minneapolis, Minnesota, United States, 55404-4526
Actively Recruiting
4
Washington University
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
5
Atlantic Healthcare System
Morristown, New Jersey, United States, 07960
Actively Recruiting
6
Carolina Biooncology Institute
Huntersville, North Carolina, United States, 28078
Actively Recruiting
7
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203-1619
Actively Recruiting
8
Texas Oncology (Balcones) - SCRI
Austin, Texas, United States, 78731-4214
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030-4000
Actively Recruiting
10
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Actively Recruiting
11
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
12
Southside Cancer Care Centre
Miranda, New South Wales, Australia, 2228
Actively Recruiting
13
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
14
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
15
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
16
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
17
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
18
Sunshine Hospital
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
Research Team
J
Jim Vasselli, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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