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Study identifier: NCT05005403 Synced from ClinicalTrials.gov · July 28, 2026
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Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

Condition: Non-Small Cell Lung Cancer · Head and Neck Squamous Cell Carcinoma · Micro Satellite Stable Colorectal Cancer  ·  Sponsor: AbbVie

PhasePhase 1
Planned participants694
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Bevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will atten…

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

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (48)

City of Hope National Medical Center /ID# 276272Duarte, California, United StatesRecruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589Irvine, California, United StatesRecruiting
USC Norris Comprehensive Cancer Center /ID# 279603Los Angeles, California, United StatesRecruiting
University of Illinois Hospital and Health Sciences System /ID# 251750Chicago, Illinois, United StatesRecruiting
University of Chicago Medical Center /ID# 276271Chicago, Illinois, United StatesRecruiting
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593Fort Wayne, Indiana, United StatesRecruiting
Community Health Network, Inc. /ID# 243011Indianapolis, Indiana, United StatesRecruiting
Norton Cancer Institute /ID# 248903Louisville, Kentucky, United StatesRecruiting
START Midwest /ID# 248685Grand Rapids, Michigan, United StatesRecruiting
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200Minneapolis, Minnesota, United StatesRecruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399Omaha, Nebraska, United StatesRecruiting
Duke Cancer Institute /ID# 276267Durham, North Carolina, United StatesRecruiting

+ 36 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05005403