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Study identifier: NCT05267626 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Advanced Solid Tumor · Metastatic Cancer · Cutaneous Melanoma  ·  Sponsor: Aulos Bioscience, Inc.

PhasePhase 1/Phase 2
Planned participants159
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jim Vasselli, MD  ·  (707) 758-6776  ·  james@aulosbio.com

Always discuss trial participation with your own doctor first.

Locations (18)

Sylvester Comprehensive Cancer Center - MiamiMiami, Florida, United StatesRecruiting
START MidwestGrand Rapids, Michigan, United StatesRecruiting
Minnesota Oncology and Hematology PAMinneapolis, Minnesota, United StatesRecruiting
Washington UniversitySt Louis, Missouri, United StatesRecruiting
Atlantic Healthcare SystemMorristown, New Jersey, United StatesRecruiting
Carolina Biooncology InstituteHuntersville, North Carolina, United StatesRecruiting
Sarah Cannon Research InstituteNashville, Tennessee, United StatesRecruiting
Texas Oncology (Balcones) - SCRIAustin, Texas, United StatesRecruiting
MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
START South Texas Accelerated Research TherapeuticsSan Antonio, Texas, United StatesRecruiting
University of Utah - Huntsman Cancer InstituteSalt Lake City, Utah, United StatesRecruiting
Southside Cancer Care CentreMiranda, New South Wales, AustraliaRecruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05267626