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
Start Date
11/1/2021
Completion Date
7/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Azirkitug
Budigalimab
Bevacizumab
Telisotuzumab Adizutecan
Conditions
Locations
City of Hope National Medical Center /ID# 276272
Duarte, California 91010
United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
Irvine, California 92618
United States
USC Norris Comprehensive Cancer Center /ID# 279603
Los Angeles, California 90033
United States
University of Illinois Hospital and Health Sciences System /ID# 251750
Chicago, Illinois 60607
United States
University of Chicago Medical Center /ID# 276271
Chicago, Illinois 60637
United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Fort Wayne, Indiana 46804
United States
Community Health Network, Inc. /ID# 243011
Indianapolis, Indiana 46250-2042
United States
Norton Cancer Institute /ID# 248903
Louisville, Kentucky 40241-2832
United States
START Midwest /ID# 248685
Grand Rapids, Michigan 49546-7062
United States
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
Minneapolis, Minnesota 55455
United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Omaha, Nebraska 68130
United States
Duke Cancer Institute /ID# 276267
Durham, North Carolina 27710
United States
Carolina BioOncology Institute /ID# 232597
Huntersville, North Carolina 28078
United States
NEXT Oncology Austin /ID# 243005
Austin, Texas 78705-1171
United States
The University of Texas MD Anderson Cancer Center /ID# 270059
Houston, Texas 77030
United States
Next Oncology Dallas /ID# 276254
Irving, Texas 75039
United States
NEXT Oncology /ID# 243007
San Antonio, Texas 78229
United States
South Texas Accelerated Research Therapeutics (START) /ID# 276268
San Antonio, Texas 78229
United States
Start Mountain Region /ID# 276270
West Valley City, Utah 84119
United States
Virginia Cancer Specialists - Fairfax /ID# 232592
Fairfax, Virginia 22031
United States
Tom Baker Cancer Centre /ID# 276206
Calgary, Alberta T2N 4N2
Canada
Princess Margaret Cancer Centre /ID# 276275
Toronto, Ontario M5G 2M9
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274
Montreal, Quebec H2X 0C1
Canada
Shamir Medical Center /ID# 276238
Beer Ya'akov, Central District 70300
Israel
Meir Medical Center /ID# 277327
Kefar Sava, Central District 4428164
Israel
Rabin Medical Center. /ID# 250497
Petah Tikva, Central District 4941492
Israel
The Chaim Sheba Medical Center /ID# 238332
Ramat Gan, Tel Aviv 5265601
Israel
Tel Aviv Sourasky Medical Center /ID# 276591
Tel Aviv, Tel Aviv 6423906
Israel
Rambam Health Care Campus /ID# 238333
Haifa, 3109601
Israel
Shaare Zedek Medical Center /ID# 276244
Jerusalem, 9103102
Israel
Hadassah Medical Center-Hebrew University /ID# 252287
Jerusalem, 91120
Israel
Aichi Cancer Center Hospital /ID# 250405
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East /ID# 238840
Kashiwa-shi, Chiba 277-8577
Japan
Kobe University Hospital /ID# 250409
Kobe, Hyōgo 650-0017
Japan
Kansai Medical University Hospital /ID# 276805
Hirakata-shi, Osaka 573-1191
Japan
Shizuoka Cancer Center /ID# 250408
Sunto-gun, Shizuoka 411-8777
Japan
National Cancer Center Hospital /ID# 238372
Chuo-ku, Tokyo 104-0045
Japan
Wakayama Medical University Hospital /ID# 276806
Wakayama, Wakayama 641-8510
Japan
National Cancer Center /ID# 252290
Goyang-si, Gyeonggido 10408
South Korea
CHA Bundang Medical Center /ID# 252291
Seongnam, Gyeonggido 13496
South Korea
Yonsei University Health System Severance Hospital /ID# 252288
Seoul, Seoul Teugbyeolsi 03722
South Korea
Asan Medical Center /ID# 252289
Seoul, Seoul Teugbyeolsi 05505
South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
Seoul, Seoul Teugbyeolsi 06591
South Korea
Taipei Medical University Shuang Ho Hospital /ID# 252449
New Taipei City, 23561
Taiwan
National Cheng Kung University Hospital /ID# 252262
Tainan, 704
Taiwan
National Taiwan University Hospital /ID# 251894
Taipei, 100
Taiwan
Taipei Medical University Hospital /ID# 252450
Taipei, 11031
Taiwan
Tri-Service General Hospital /ID# 252263
Taipei, 11490
Taiwan