A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan
Summary
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 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.
Arms & interventions
- DrugAzirkitug
Intravenous (IV) Infusion
- DrugBudigalimab
Intravenous (IV) Infusion
- DrugBevacizumab
Intravenous (IV) Infusion
- DrugTelisotuzumab Adizutecan
Intravenous (IV) Infusion
Outcome measures
Primary
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 Azirkitug
Maximum Observed Serum Concentration (Cmax) of azirkitug.
Time frame: Up to 2 Years
Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug
Time to maximum Observed Serum Concentration (Tmax) of azirkitug.
Time frame: Up to 2 Years
Terminal Elimination Half-Life (t1/2) of Azirkitug
Terminal elimination half-life (t1/2) of azirkitug.
Time frame: Up to 2 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug
Area under the serum concentration versus time curve (AUC) of azirkitug.
Time frame: Up to 2 Years
Azirkitug Antidrug Antibody (ADA)
Incidence and concentration of azirkitug anti-drug antibodies.
Time frame: Up to 2 Years
Azirkitug Neutralizing Antidrug Antibody (nADA)
Incidence and concentration of azirkitug neutralizing anti-drug antibodies.
Time frame: Up to 2 Years
Cmax of Budigalimab
Cmax of budigalimab.
Time frame: Up to 2 Years
Tmax of Budigalimab
Tmax of budigalimab.
Time frame: Up to 2 Years
t1/2 of Budigalimab
t1/2 of budigalimab.
Time frame: Up to 2 Years
AUC of Budigalimab
AUC of budigalimab.
Time frame: Up to 2 Years
Budigalimab ADA
Incidence and concentration of budigalimab ADA.
Time frame: Up to 2 Years
Budigalimab nADA
Incidence and concentration of budigalimab nADA.
Time frame: Up to 2 Years
Cmax of Telisotuzumab Adizutecan
Cmax of telisotuzumab adizutecan.
Time frame: Up to 2 Years
Tmax of Telisotuzumab Adizutecan
Tmax of telisotuzumab adizutecan.
Time frame: Up to 2 Years
t1/2 of Telisotuzumab Adizutecan
t1/2 of telisotuzumab adizutecan.
Time frame: Up to 2 Years
AUC of Telisotuzumab Adizutecan
AUC of telisotuzumab adizutecan.
Time frame: Up to 2 Years
Telisotuzumab Adizutecan ADA
Incidence and concentration of telisotuzumab adizutecan ADA.
Time frame: Up to 2 Years
Telisotuzumab Adizutecan nADA
Incidence and concentration of telisotuzumab adizutecan nADA.
Time frame: Up to 2 Years
Eligibility criteria
Study locations (19)
City of Hope National Medical Center /ID# 276272
Duarte, California, 91010
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
Irvine, California, 92618
USC Norris Comprehensive Cancer Center /ID# 279603
Los Angeles, California, 90033
University of Illinois Hospital and Health Sciences System /ID# 251750
Chicago, Illinois, 60607
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Fort Wayne, Indiana, 46804
Community Health Network, Inc. /ID# 243011
Indianapolis, Indiana, 46250-2042
Norton Cancer Institute /ID# 248903
Louisville, Kentucky, 40241-2832
START Midwest /ID# 248685
Grand Rapids, Michigan, 49546-7062
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
Minneapolis, Minnesota, 55455
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Omaha, Nebraska, 68130
Duke Cancer Institute /ID# 276267
Durham, North Carolina, 27710
Carolina BioOncology Institute /ID# 232597
Huntersville, North Carolina, 28078
NEXT Oncology Austin /ID# 243005
Austin, Texas, 78705-1171
The University of Texas MD Anderson Cancer Center /ID# 270059
Houston, Texas, 77030
Next Oncology Dallas /ID# 276254
Irving, Texas, 75039
NEXT Oncology /ID# 243007
San Antonio, Texas, 78229
South Texas Accelerated Research Therapeutics (START) /ID# 276268
San Antonio, Texas, 78229
Start Mountain Region /ID# 276270
West Valley City, Utah, 84119
Virginia Cancer Specialists - Fairfax /ID# 232592
Fairfax, Virginia, 22031