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Study of AU-007 for Advanced Solid Tumors

This study is testing a new drug called AU-007 (imneskibart) for people with advanced solid tumors, including metastatic cancer, cutaneous melanoma, and non-small cell lung cancer. AU-007 is a monoclonal antibody, a type of drug that targets specific substances in the body. It will be given alone or in combination with aldesleukin (another drug that targets IL-2), and sometimes also with avelumab or nivolumab (drugs that target PD-L1 or PD-1). The main goals are to find out if AU-007 is safe, how well people tolerate it, and to determine the best dose. You might be able to join if your cancer has measurable disease and you have either progressed on or cannot receive standard treatments. The study is currently recruiting 159 participants.

Study design
This is an open-label, multi-center Phase 1/2 study, meaning both you and your doctors will know which treatment you are receiving. It is designed to evaluate AU-007 in different combinations and doses.
What's involved
The study will evaluate safety and tolerability from the first day of treatment until 28 days after your last dose.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured up to 28 days after the last dose of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05267626

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
PHASE1Ages 18+InterventionalTreatment
Aulos Bioscience, Inc.
~159 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:AU-007AldesleukinAvelumabNivolumab

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the safety and tolerability of AU-007
Measured over Day 1 thru end of treatment (EOT) visit (28 days after last dose)
+1 more outcome measured

Conditions

Advanced Solid Tumor
Metastatic Cancer
Cutaneous Melanoma
Non-Small Cell Lung Cancer

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NCT05267626

Where you'd take part

This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atlantic Healthcare System

    Morristown, New Jerseystudy coordinator listed

    Recruiting

  • Austin Health

    Heidelberg, Victoria, Australiastudy coordinator listed

    Recruiting

  • Carolina Biooncology Institute

    Huntersville, North Carolinastudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Minnesota Oncology and Hematology PA

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Monash Health

    Clayton, Victoria, Australiastudy coordinator listed

    Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, Australiastudy coordinator listed

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • James Vasselli, MD · STUDY_CHAIR · Aulos Bioscience, Inc.

Who to contact

Jim Vasselli, MD
[email protected]
(707) 758-6776
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Evaluate the safety and tolerability of AU-007Day 1 thru end of treatment (EOT) visit (28 days after last dose)

    Measured by the frequency of DLTs (Dose limiting toxicity) and safety profile

  • Establish the maximum tolerated dose (MTD) and/or RP2DDay 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