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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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.

Jim Vasselli, MD contact

(707) 758-6776

james@aulosbio.com

17 sites in 2 countries

United States10 sites, 10 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

    Recruiting

Other trials in United States

Australia7 sites, 7 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

    Recruiting

Other trials in Australia

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.

Being tested
AU-007, Aldesleukin, Avelumab, Nivolumab
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 groups in NCT05267626
Study groupRoleWhat they receive
AU-007 MonotherapyExperimentalAU-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 aldesleukinExperimentalAU-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 concomitantlyExperimentalAU-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 avelumabExperimentalAU-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 nivolumabExperimentalAU-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.

  1. 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)

  2. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Magnitude of cytokine changes in the blood after dosing

    Measured: Day 1 thru EOT visit (28 days after last dose)

  6. 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)

  7. 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.

  1. First posted4 Mar 2022
  2. Study start4 Apr 2022
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jim Vasselli, MD ((707) 758-6776, james@aulosbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety and tolerability of AU-007 (time frame: Day 1 thru end of treatment (EOT) visit (28 days after last dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05267626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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Clinical Trial NCT05267626 | AzTrials