NCT05267626RecruitingPhase 1/2
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, 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
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 159 (estimated)
- First submitted
- 10 Feb 2022
- Start date
- 4 Apr 2022
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Aulos Bioscience, Inc.
- Diseases
- Head and neck cancer, Kidney cancer, Bladder cancer, Melanoma, Lung cancer, Gastric and esophageal cancer
- NCT number
- NCT05267626
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 159
- From 4 Apr 2022 to the primary completion date, 28 Feb 2027
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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
- 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
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southern Oncology Clinical Research Unit Coordinator of this site? Confirm its status | Bedford Park | Australia | Recruiting |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Peninsula & South Eastern Haematology and Oncology Group Coordinator of this site? Confirm its status | Frankston | Australia | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Southside Cancer Care Centre Coordinator of this site? Confirm its status | Miranda | Australia | Recruiting |
| Sunshine Hospital Coordinator of this site? Confirm its status | Saint Albans | Australia | Recruiting |
| Texas Oncology (Balcones) - SCRI Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Carolina Biooncology Institute Coordinator of this site? Confirm its status | Huntersville | United States | Recruiting |
| Sylvester Comprehensive Cancer Center Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Minnesota Oncology and Hematology PA Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| START South Texas Accelerated Research Therapeutics Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.