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 (ABBV-514) as a monotherapy and in combination with Budigalimab or Bevacizumab,. Bevacizumab is an approved product, while Budigalimab and Azirkitug (ABBV-514) 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 (ABBV-514) will be explored. Each treatment arm receives a different dose of Azirkitug (ABBV-514) in monotherapy and in combination with Budigalimab or Bevacizumab. Approximately 512 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive Azirkitug (ABBV-514) as a monotherapy or in combination with Budigalimab or Bevacizumab 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 attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
512
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Intravenous (IV) Infusion
City of Hope National Medical Center /ID# 276272
Duarte, California, United States
RECRUITINGUniversity of Illinois Hospital and Health Sciences System /ID# 251750
Chicago, Illinois, United States
RECRUITINGFort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Fort Wayne, Indiana, United States
RECRUITINGCommunity Health Network, Inc. /ID# 243011
Indianapolis, Indiana, United States
Number of Participants with Adverse Events (AE)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of ABBV-514
Maximum Observed Serum Concentration (Cmax) of of ABBV-514.
Time frame: Up to 2 Years
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514
Time to maximum Observed Serum Concentration (Tmax) of of ABBV-514.
Time frame: Up to 2 Years
Terminal Elimination Half-Life (t1/2) of ABBV-514
Terminal elimination half-life (t1/2) of ABBV-514.
Time frame: Up to 2 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514
Area under the serum concentration versus time curve (AUC) of ABBV-514.
Time frame: Up to 2 Years
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Time frame: Up to 2 Years
Neutralizing Antidrug Antibody (nADA)
Incidence and concentration of neutralizing anti-drug antibodies.
Time frame: Up to 2 Years
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Norton Cancer Institute /ID# 248903
Louisville, Kentucky, United States
RECRUITINGSTART Midwest /ID# 248685
Grand Rapids, Michigan, United States
RECRUITINGNebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Omaha, Nebraska, United States
RECRUITINGCarolina BioOncology Institute /ID# 232597
Huntersville, North Carolina, United States
RECRUITINGNEXT Oncology Austin /ID# 243005
Austin, Texas, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center /ID# 270059
Houston, Texas, United States
RECRUITING...and 25 more locations