Advanced Solid TumorPhase 1/2NCT05267626
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
A Phase 1/2 study testing AU-007, Aldesleukin and Avelumab in people with Advanced Solid Tumor and Metastatic Cancer, run by Aulos Bioscience, Inc. at 17 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma
- What is being tested?
- AU-007, Aldesleukin and Avelumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 4 Apr 2022to 28 Feb 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States10 sites, 10 recruiting
- Recruiting
Texas Oncology (Balcones) - SCRI
Austin, Texas, 78731-4214
Jeffrey Yorio, 512-427-9400, jeff.yorio@usoncology.com
- Recruiting
START Midwest
Grand Rapids, Michigan, 49503-2563
Nehal Lakhani, 616-954-5554, nehal.lakhani@startmidwest.com
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030-4000
George Blumenschein, 713-792-6363, gblumens@mdanderson.org
- Recruiting
Carolina Biooncology Institute
Huntersville, North Carolina, 28078
John Powderly, MD, 704-947-6599, jpowderly@carolinabiooncology.org
- Recruiting
Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136-1002
Jose Lutzky, 305-535-3356, jose.lutzky@med.mia.mi.edu
- Recruiting
Minnesota Oncology and Hematology PA
Minneapolis, Minnesota, 55404-4526
Eric Lander, 612-884-6300, Eric.Lander@usoncology.com
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203-1619
Meredith McKean, 615-524-4461, meredith.mckean@scri.com
- Recruiting
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Siwen Hu-Lieskovan, 864-334-0141, siwen.hu-lieskovan@hci.utah.edu
- Recruiting
START South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Drew Rasco, 210-593-5265, drew.rasco@startsa.com
- Recruiting
Washington University
St Louis, Missouri, 63110-1010
Ramaswamy Govindan, 314-867-3627, rgovindan@wustl.edu
Australia7 sites, 7 recruiting
- Recruiting
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
Ganessan Kichenadasse, +61 4 9167 9039, clinicaltrials@socru.org.au
- Recruiting
Monash Health
Clayton, Victoria, 3168
Sophia Frentzas, +61 3 9076 7467, sophia.frentzas@monashhealth.org
- Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Dr. V Ganju, +61 3 9781 5244, vg@paso.com.au
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Andrew Weickhardt, +61 3 9496 9918, Andrew.WEICKHARDT@austin.org.au
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Andrew Haydon, MD, +61390766963, andrew.haydon@monash.edu
- Recruiting
Southside Cancer Care Centre
Miranda, New South Wales, 2228
Paul DeSouza, +61 02 9553 9588, P.DeSouza@westernsydney.edu.au
- Recruiting
Sunshine Hospital
Saint Albans, Victoria, 3021
Catherine Oakman, +61 3 8345 6666, catherine.oakman@wh.org.au
About this study
Official title: A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion 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.
Read the detailed description
This is a first in human, multicenter, open-label Phase 1-2 study evaluating the safety, tolerability, and initial efficacy of AU-007 with or without aldesleukin, in patients with unresectable locally advanced or metastatic cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy.
Part 1 consists of 3 escalation Arms, each starting with a single 1+2 escalation cohort followed by 3+3 escalation cohorts to define the RP2D or maximum tolerated dose (MTD).
The study begins in Arm A evaluating escalating doses of AU-007 (Q2w) in sequential escalation cohorts to define RP2D or MTD.
In Arm B, AU-007 (Q2w) is evaluated in combination with a single dose of aldesleukin given with the first AU-007 dose. AU-007 is administered Q2w with an escalating single aldesleukin dose in sequential escalation cohorts.
In Arm C, AU-007 is evaluated in combination with aldesleukin, both given Q2w. AU-007 will be administered with an escalating dose of aldesleukin in each sequential Arm C escalation cohort.
The Part 2 cohort expansion portion of the study consists of up to three expansion Arms evaluating the initial efficacy of the RP2D (AU-007 plus a single loading dose of aldesleukin) in selected solid tumor types, prioritizing cutaneous melanoma and non-small cell lung cancer (NSCLC).
Part 3 evaluates the safety of AU-007 in combination with aldesleukin and avelumab, followed by one expansion cohort, in NSCLC.
Part 4 evaluates the safety of AU-007 plus aldesleukin in combination with nivolumab, followed by one expansion cohort, in cutaneous melanoma.
- Keywords
- IL-2 CD25, IL-2Ra, Melanoma, Head and neck squamous cell carcinoma, Urothelial cancer, Gastric Cancer, Gastro-esophageal cancer, CD25, IL-2, NSCLC, Bladder Cancer, Merkel Cell Cancer, Proleukin, Immune Therapy, Immunotherapy, Cutaneous Squamous Cell Cancer, Cytokine, Anti-PD-L1, Non-small cell lung cancer, Clear cell renal cell cancer
- Medical subject headings
- Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Diabetes Mellitus, Insulin-Dependent, 10, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AU-007Drug
Monoclonal Antibody Targeting IL-2
AldesleukinDrug
IL-2
AvelumabDrug
Monoclonal Antibody Targeting PD-L1
NivolumabDrug
Monoclonal Antibody Targeting PD-1
| Study group | Role | What they receive |
|---|---|---|
| AU-007 Monotherapy | Experimental | AU-007 (Q2w) administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort
(Complete; no longer enrolling) Receives: Drug: AU-007 |
| AU-007 combined with a single dose of aldesleukin | Experimental | AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose. Receives: Drug: AU-007; Drug: Aldesleukin |
| AU-007 combined with aldesleukin given concomitantly | Experimental | AU-007 administered in combination with aldesleukin, both administered Q2w
(Complete; no longer enrolling) Receives: Drug: AU-007; Drug: Aldesleukin |
| AU-007 plus aldesleukin in combination avelumab | Experimental | AU-007 and avelumab administered Q2w with a single dose of aldesleukin with the initial AU-007 dose Receives: Drug: AU-007; Drug: Aldesleukin; Drug: Avelumab |
| AU-007 plus aldesleukin in combination with nivolumab | Experimental | AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose.
Nivolumab will be administered Q4w. Receives: Drug: AU-007; Drug: Aldesleukin; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of AU-007
Measured by the frequency of DLTs (Dose limiting toxicity) and safety profile
Measured: Day 1 thru end of treatment (EOT) visit (28 days after last dose)
Establish the maximum tolerated dose (MTD) and/or RP2D
With AU-007 alone or in combination with aldesleukin measured by pharmacokinetics (PK), pharmacodynamics (PD), and Biomarkers
Measured: Day 1 thru EOT visit (28 days after last dose)
Secondary outcomes (7)
Magnitude of PK changes in the blood after dosing determined by area under the curve (AUC) of AU-007
The AUC of AU-007 will be measured at different timepoints after AU-007 administration
Measured: Day 1 thru EOT visit (28 days after last dose)
Magnitude of PK changes in the blood after dosing determined by maximum concentration (Cmax) of AU-007
The Cmax of AU-007 will be measured at different timepoints after AU-007 administration
Measured: Day 1 thru EOT visit (28 days after last dose)
Magnitude of PK changes in the blood after dosing determined by time of maximum concentration (Tmax)
The Tmax of AU-007 will be measured at different timepoints after AU-007 administration
Measured: Day 1 thru EOT visit (28 days after last dose)
Magnitude of PK changes in the blood after dosing determined by Half-life (T1/2) of AU-007
The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration
Measured: Day 1 thru EOT visit (28 days after last dose)
Magnitude of cytokine changes in the blood after dosing
Measured: Day 1 thru EOT visit (28 days after last dose)
Magnitude of immunogenicity after dosing with AU-007 alone or in combination with aldesleukin, AU-007 in combination with aldesleukin and avelumab or nivolumab
Assessed by summarizing the number of patients who develop detectable anti-drug antibodies (ADAs) at different timepoints after AU-007 alone or in combination with aldesleukin, AU-007 in combination with aldesleukin and avelumab, or nivolumab
Measured: Day 1 thru EOT visit (28 days after last dose)
Evaluate the preliminary anti-tumor activity of AU-007 alone, in combination with aldesleukin, in combination with aldesleukin and avelumab, and AU-007 plus aldesleukin with nivolumab in patients with unresectable locally advanced or metastatic cancer
Clinical anti-tumor activity will be evaluated using conventional Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST v1.1.
Measured: Day 1 thru EOT visit (28 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start4 Apr 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aulos Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Vasselli, MD, Study chair, Aulos Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267626
- Sponsor's protocol ID
- CP-AU-007-01
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No