Clinical trial 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 monoclonal antibody being studied as a potential treatment for advanced solid tumors. It is designed to bind to interleukin‑2 (IL‑2) and modify the immune system’s response to cancer.
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 study is testing whether AU-007 is safe and how well it works in people with advanced solid tumors.
- Who it's for
- You may be able to join if you have an advanced solid tumor such as melanoma, non‑small cell lung cancer, or another metastatic cancer.
- What's involved
- You would receive IV infusions of AU-007, sometimes together with a single dose of aldesleukin, and possibly with other medicines. You will have clinic visits for the infusions and for safety checks.
- Time commitment
- The study lasts several months with clinic visits about every two weeks for treatments and follow‑up checks.
- 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
- 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)
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
- 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.
- 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.
- 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.
- 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.
- 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...
- 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.
- 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 is enrolling
- Miami, Florida, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, 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, but 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?
This study is enrolling now at Miami, Florida, United States; Grand Rapids, Michigan, United States; Minneapolis, Minnesota, United States; St Louis, Missouri, United States; Huntersville, North Carolina, United States; Nashville, Tennessee, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.