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 (NCT05267626)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Sylvester Comprehensive Cancer Center - Miami — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- Sylvester Comprehensive Cancer Center - Miami — Miami, Florida
- START Midwest — Grand Rapids, Michigan
- Minnesota Oncology and Hematology PA — Minneapolis, Minnesota
- Washington University — St Louis, Missouri
- Atlantic Healthcare System — Morristown, New Jersey
- Carolina Biooncology Institute — Huntersville, North Carolina
- Sarah Cannon Research Institute — Nashville, Tennessee
- Texas Oncology (Balcones) - SCRI — Austin, Texas
- MD Anderson Cancer Center — Houston, Texas
- START South Texas Accelerated Research Therapeutics — San Antonio, Texas
- University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah
- Southside Cancer Care Centre — Miranda, New South Wales
- Southern Oncology Clinical Research Unit — Bedford Park, South Australia
- Monash Health — Clayton, Victoria
- Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria
- Austin Health — Heidelberg, Victoria
- The Alfred Hospital — Melbourne, Victoria
- Sunshine Hospital — Saint Albans, Victoria
📞 Contact the Study Coordinator
Phone: (707) 758-6776
Email: james@aulosbio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumor
- Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression — Iowa City, Iowa
- A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors — Glendale, California
- QTX3046 in Patients With KRAS G12D Mutations — Grand Rapids, Michigan
- A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors — Houston, Texas
- First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer — Fullerton, California
- A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors — San Antonio, Texas
Explore by condition: All Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.