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New treatment option for Advanced Solid Tumor
Official title 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
ClinicalTrials.gov ID: NCT05267626
What this study is testing
What is AU-007?
AU-007 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Selected
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Selected
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Morristown, New Jersey, United States
- Huntersville, North Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Miranda, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Clayton, Victoria, Australia
- Frankston, Victoria, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- Saint Albans, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Grand Rapids, Michigan, United States; Minneapolis, Minnesota, United States; St Louis, Missouri, United States; Morristown, New Jersey, United States; Huntersville, North Carolina, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.