Sponsor:
AbbVie
Code:
NCT05005403
Conditions
Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Micro Satellite Stable Colorectal Cancer
Gastric/Esophageal Cancer
High-Grade Serous Ovarian Cancer
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Azirkitug
Budigalimab
Bevacizumab
Telisotuzumab Adizutecan
Brief summary:
Conditions
Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Micro Satellite Stable Colorectal Cancer
Gastric/Esophageal Cancer
High-Grade Serous Ovarian Cancer
Study ID
NCT05005403
Start date
Nov 1, 2021
Status verified date
Jun, 2026
Completion date
Jul, 2027
Anticipated
Primary completion date
Jul, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
694 participants
Anticipated
Allocation
Non randomized
Intervention Model
Sequential
Primary purpose
Treatment
Arms
experimental: Part 1 Dose Escalation: Azirkitug
experimental: Part 1 Dose Escalation: Azirkitug + Budigalimab
experimental: Part 2 Dose Expansion: Azirkitug
experimental: Part 2 Dose Expansion: Azirkitug + Budigalimab
experimental: Part 3 Dose Expansion: Azirkitug + Budigalimab
experimental: Part 4 Dose Expansion: Azirkitug
experimental: Part 4 Dose Expansion: Azirkitug + Budigalimab
experimental: Part 4 Dose Optimization and Randomization: Azirkitug
experimental: Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab
experimental: Part 5 Dose Expansion: Azirkitug + Budigalimab
experimental: Part 6 Dose Expansion: Azirkitug + Budigalimab
experimental: Part 7 Dose Expansion: Azirkitug + Budigalimab
experimental: Part 8 Safety Lead In: Azirkitug + Bevacizumab
experimental: Part 8 Dose Expansion: Azirkitug + Bevacizumab
experimental: Part 9 Dose Expansion: Azirkitug + Budigalimab
experimental: Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan
experimental: Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan
Interventions
Azirkitug
Budigalimab
Bevacizumab
Telisotuzumab Adizutecan
Primary outcome measure
Central contacts
Locations
City of Hope National Medical Center /ID# 276272
Recruiting
Duarte, California, United States, 91010
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
Recruiting
Irvine, California, United States, 92618
USC Norris Comprehensive Cancer Center /ID# 279603
Recruiting
Los Angeles, California, United States, 90033
University of Illinois Hospital and Health Sciences System /ID# 251750
Recruiting
Chicago, Illinois, United States, 60607
University of Chicago Medical Center /ID# 276271
Recruiting
Chicago, Illinois, United States, 60637
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Recruiting
Fort Wayne, Indiana, United States, 46804
Community Health Network, Inc. /ID# 243011
Recruiting
Indianapolis, Indiana, United States, 46250-2042
Norton Cancer Institute /ID# 248903
Recruiting
Louisville, Kentucky, United States, 40241-2832
START Midwest /ID# 248685
Recruiting
Grand Rapids, Michigan, United States, 49546-7062
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
Recruiting
Minneapolis, Minnesota, United States, 55455
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Recruiting
Omaha, Nebraska, United States, 68130
Duke Cancer Institute /ID# 276267
Recruiting
Durham, North Carolina, United States, 27710
Carolina BioOncology Institute /ID# 232597
Recruiting
Huntersville, North Carolina, United States, 28078
Contacts
Site Coordinator
844-663-3742NEXT Oncology Austin /ID# 243005
Recruiting
Austin, Texas, United States, 78705-1171
The University of Texas MD Anderson Cancer Center /ID# 270059
Recruiting
Houston, Texas, United States, 77030
Next Oncology Dallas /ID# 276254
Recruiting
Irving, Texas, United States, 75039
NEXT Oncology /ID# 243007
Recruiting
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapeutics (START) /ID# 276268
Recruiting
San Antonio, Texas, United States, 78229
Start Mountain Region /ID# 276270
Recruiting
West Valley City, Utah, United States, 84119
Virginia Cancer Specialists - Fairfax /ID# 232592
Recruiting
Fairfax, Virginia, United States, 22031
Tom Baker Cancer Centre /ID# 276206
Recruiting
Calgary, Alberta, Canada, T2N 4N2
Princess Margaret Cancer Centre /ID# 276275
Recruiting
Toronto, Ontario, Canada, M5G 2M9
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274
Recruiting
Montreal, Quebec, Canada, H2X 0C1
Sponsor
AbbVie
Last update posted
Jun 23, 2026
Last verified
Jun, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-23.