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

May 15, 2026 updated by: Aulos Bioscience, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

159

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Miranda, New South Wales, Australia, 2228
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Southern Oncology Clinical Research Unit
        • Contact:
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula & South Eastern Haematology and Oncology Group
        • Contact:
      • Heidelberg, Victoria, Australia, 3084
      • Melbourne, Victoria, Australia, 3004
      • Saint Albans, Victoria, Australia, 3021
  • United States
    • Florida
      • Miami, Florida, United States, 33136-1002
        • Recruiting
        • Sylvester Comprehensive Cancer Center - Miami
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49503-2563
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404-4526
        • Recruiting
        • Minnesota Oncology and Hematology PA
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110-1010
        • Recruiting
        • Washington University
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
    • Tennessee
      • Nashville, Tennessee, United States, 37203-1619
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
    • Texas
      • Austin, Texas, United States, 78731-4214
        • Recruiting
        • Texas Oncology (Balcones) - SCRI
        • Contact:
      • Houston, Texas, United States, 77030-4000
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • START South Texas Accelerated Research Therapeutics
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Selected Inclusion Criteria:

  • Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI
  • Part 2 includes but is not limited to:

  • Cutaneous melanoma that is either locally unresectable or metastatic:

    • BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4
    • BRAF mutation: patients who refused BRAF+MEK inhibitor
    • Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3)
    • Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)
    • LDH ≤ 2.5 x ULN
  • NSCLC: Unresectable locally advanced or metastatic PD-L1-positive (tumor proportion score [TPS] ≥ 1%) NSCLC not harboring an activating EGFR mutation or ALK rearrangement and has progressed during or following treatment with an anti-PDx with or without platinum-based chemotherapy
  • Part 3: NSCLC as described above

  • Part 4: cutaneous melanoma

    • Unresectable locally advanced or metastatic cutaneous melanoma that has progressed during or following treatment with an anti-PDx (unless ineligible for anti-PDx therapy)
    • Patients with BRAF mutations must either be ineligible for or have refused a BRAF+MEK inhibitor
    • Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3).
    • Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet)
    • LDH ≤ 2.5 x ULN
  • Female patients of childbearing potential must have a negative serum or urine pregnancy test performed within 72 hours prior to the initiation of study drug administration. Female patients of childbearing potential must be willing to use two forms of contraception throughout the study, starting with Screening through 60 days after the last dose of study drug (or 5 months after the last dose of study drug for patients receiving nivolumab). Abstinence is acceptable if this is the established and the preferred contraception method for the patient
  • Male patients with partners of childbearing potential must use barrier contraception from the time of consent through 60 days after discontinuation of study drug and must not donate sperm during this period. In addition, male patients should have their partners use contraception (as documented for female patients) for the same period of time
  • Patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) prior to enrollment must have checkpoint inhibitor immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the checkpoint inhibitor) to be eligible for enrollment. Patients who experienced previous checkpoint inhibitor-related hypothyroidism are eligible for the study regardless of grade resolution if well controlled on thyroid hormone replacement therapy
  • Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:
  • No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids ≥ 10 mg prednisone/day or equivalent)
  • No concurrent leptomeningeal disease or cord compression

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AU-007 Monotherapy

AU-007 (Q2w) administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort

(Complete; no longer enrolling)
Drug: AU-007
Monoclonal Antibody Targeting IL-2
Experimental: AU-007 combined with a single dose of aldesleukin
AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose.
Drug: AU-007
Monoclonal Antibody Targeting IL-2
Drug: Aldesleukin
IL-2
Experimental: AU-007 combined with aldesleukin given concomitantly

AU-007 administered in combination with aldesleukin, both administered Q2w

(Complete; no longer enrolling)
Drug: AU-007
Monoclonal Antibody Targeting IL-2
Drug: Aldesleukin
IL-2
Experimental: AU-007 plus aldesleukin in combination avelumab
AU-007 and avelumab administered Q2w with a single dose of aldesleukin with the initial AU-007 dose
Drug: AU-007
Monoclonal Antibody Targeting IL-2
Drug: Aldesleukin
IL-2
Drug: Avelumab
Monoclonal Antibody Targeting PD-L1
Experimental: AU-007 plus aldesleukin in combination with nivolumab

AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose.

Nivolumab will be administered Q4w.
Drug: AU-007
Monoclonal Antibody Targeting IL-2
Drug: Aldesleukin
IL-2
Drug: Nivolumab
Monoclonal Antibody Targeting PD-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of AU-007
Time Frame: Day 1 thru end of treatment (EOT) visit (28 days after last dose)
Measured by the frequency of DLTs (Dose limiting toxicity) and safety profile
Day 1 thru end of treatment (EOT) visit (28 days after last dose)
Establish the maximum tolerated dose (MTD) and/or RP2D
Time Frame: Day 1 thru EOT visit (28 days after last dose)
With AU-007 alone or in combination with aldesleukin measured by pharmacokinetics (PK), pharmacodynamics (PD), and Biomarkers
Day 1 thru EOT visit (28 days after last dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitude of cytokine changes in the blood after dosing
Time Frame: Day 1 thru EOT visit (28 days after last dose)
Day 1 thru EOT visit (28 days after last dose)
Magnitude of PK changes in the blood after dosing determined by area under the curve (AUC) of AU-007
Time Frame: Day 1 thru EOT visit (28 days after last dose)
The AUC of AU-007 will be measured at different timepoints after AU-007 administration
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
Time Frame: Day 1 thru EOT visit (28 days after last dose)
The Cmax of AU-007 will be measured at different timepoints after AU-007 administration
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)
Time Frame: Day 1 thru EOT visit (28 days after last dose)
The Tmax of AU-007 will be measured at different timepoints after AU-007 administration
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
Time Frame: Day 1 thru EOT visit (28 days after last dose)
The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration
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
Time Frame: Day 1 thru EOT visit (28 days after last dose)
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
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
Time Frame: Day 1 thru EOT visit (28 days after last dose)
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.
Day 1 thru EOT visit (28 days after last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aulos Bioscience, Inc.

Investigators

  • Study Chair: James Vasselli, MD, Aulos Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

June 12, 2026

Study Completion (Estimated)

June 12, 2026

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-AU-007-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on AU-007

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe