Recruiting
Phase 1
Phase 2

AU-007

Sponsor:

Aulos Bioscience, Inc.

Code:

NCT05267626

Conditions

Advanced Solid Tumor

Metastatic Cancer

Cutaneous Melanoma

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AU-007

Aldesleukin

Avelumab

Nivolumab

Study Details

Brief 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. 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

Advanced Solid Tumor

Metastatic Cancer

Cutaneous Melanoma

Non-Small Cell Lung Cancer

Study ID

NCT05267626

Start date

Apr 4, 2022

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

159 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AU-007 Monotherapy

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

(Complete; no longer enrolling)

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.

experimental: AU-007 combined with aldesleukin given concomitantly

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

(Complete; no longer enrolling)

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

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.

Interventions

AU-007

Monoclonal Antibody Targeting IL-2

Aldesleukin

IL-2

Avelumab

Monoclonal Antibody Targeting PD-L1

Nivolumab

Monoclonal Antibody Targeting PD-1

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) ]
  • Establish the maximum tolerated dose (MTD) and/or RP2D [ Time Frame: Day 1 thru EOT visit (28 days after last dose) ]

Central Contacts and Locations

Central contacts

Jim Vasselli, MD

(707) 758-6776james@aulosbio.com

Locations

Sylvester Comprehensive Cancer Center - Miami

Recruiting

Miami, Florida, United States, 33136-1002

Contacts

Jose Lutzky

305-535-3356jose.lutzky@med.mia.mi.edu

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49503-2563

Contacts

Nehal Lakhani

616-954-5554nehal.lakhani@startmidwest.com

Minnesota Oncology and Hematology PA

Recruiting

Minneapolis, Minnesota, United States, 55404-4526

Contacts

Eric Lander

612-884-6300Eric.Lander@usoncology.com

Washington University

Recruiting

St Louis, Missouri, United States, 63110-1010

Contacts

Ramaswamy Govindan

314-867-3627rgovindan@wustl.edu

Atlantic Healthcare System

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Eric Whitman

973-971-7111eric.whitman@atlantichealth.org

Carolina Biooncology Institute

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

John Powderly, MD

704-947-6599jpowderly@carolinabiooncology.org

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203-1619

Contacts

Meredith McKean

615-524-4461meredith.mckean@scri.com

Texas Oncology (Balcones) - SCRI

Recruiting

Austin, Texas, United States, 78731-4214

Contacts

Jeffrey Yorio

512-427-9400jeff.yorio@usoncology.com

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4000

Contacts

George Blumenschein

713-792-6363gblumens@mdanderson.org

START South Texas Accelerated Research Therapeutics

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Drew Rasco

210-593-5265drew.rasco@startsa.com

University of Utah - Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Siwen Hu-Lieskovan

864-334-0141siwen.hu-lieskovan@hci.utah.edu

More Information

Sponsor

Aulos Bioscience, Inc.

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

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
  • imneskibart

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aulos Bioscience, Inc. on 2026-07-30.