Actively Recruiting
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
Led by AbbVie · Updated on 2026-05-13
694
Participants Needed
45
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-treatment biopsy or archived tissue within 6 months without treatment in between
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and life expectancy of at least 3 months
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Laboratory values meeting protocol requirements
- NSCLC: advanced or metastatic disease progressed on standard care including chemotherapy and prior anti-PD-(L)1 antibodies; eligible if failed targeted therapies for actionable gene alterations
- HNSCC: advanced or metastatic disease progressed on platinum and PD-1/PD-L1 therapies in recurrent or metastatic setting
- Micro Satellite Stable Colorectal Cancer (MSS-CRC): progressed on multiple therapies including Oxaliplatin, Irinotecan, anti-EGFR, VEGF or VEGFR therapies, and other targeted treatments; not MSI-high or MMR-deficient
- Gastric and Gastroesophageal Junction adenocarcinoma: advanced or metastatic disease progressed on at least one prior chemotherapy and if applicable immune checkpoint inhibitor or HER2 therapy
- High-Grade Serous Ovarian Cancer: progressed serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after standard care; not eligible for surgery; platinum-resistant with no more than 5 prior therapies
- Pancreatic Adenocarcinoma: advanced or metastatic disease progressed after standard care, including adenosquamous carcinoma and post-Whipple patients
- Triple Negative Breast Cancer: progressed after 1 or 2 systemic therapies including taxane; treatment-naive to immunotherapy targeting T-cell co-stimulation
You will not qualify if you...
- Pancreatic Ductal Adenocarcinoma excluding neuroendocrine or acinar pancreatic carcinoma; participants with coagulopathy or history/risk of deep vein thrombosis or pulmonary embolism
- Major surgery within 28 days before dosing
- Active autoimmune or immunodeficiency disease with limited exceptions
- Combination treatment excludes participants with grade 3 or higher immune-mediated toxicity from prior anti-PD-1/PD-L1 treatment, interstitial lung disease, or hypersensitivity; may also exclude those with significant cardiac issues
- Pregnancy
- Recent anticancer therapy within 5 half-lives or 28 days (whichever is shorter), agents targeting Chemokine Receptor 8, live vaccines, or immunosuppressive medications with limited exceptions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
City of Hope National Medical Center /ID# 276272
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
Irvine, California, United States, 92618
Actively Recruiting
3
University of Illinois Hospital and Health Sciences System /ID# 251750
Chicago, Illinois, United States, 60607
Actively Recruiting
4
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
5
Community Health Network, Inc. /ID# 243011
Indianapolis, Indiana, United States, 46250-2042
Actively Recruiting
6
Norton Cancer Institute /ID# 248903
Louisville, Kentucky, United States, 40241-2832
Actively Recruiting
7
START Midwest /ID# 248685
Grand Rapids, Michigan, United States, 49546-7062
Actively Recruiting
8
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
9
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Omaha, Nebraska, United States, 68130
Actively Recruiting
10
Duke Cancer Institute /ID# 276267
Durham, North Carolina, United States, 27710
Actively Recruiting
11
Carolina BioOncology Institute /ID# 232597
Huntersville, North Carolina, United States, 28078
Actively Recruiting
12
NEXT Oncology Austin /ID# 243005
Austin, Texas, United States, 78705-1171
Actively Recruiting
13
The University of Texas MD Anderson Cancer Center /ID# 270059
Houston, Texas, United States, 77030
Actively Recruiting
14
Next Oncology - Irving /ID# 276254
Irving, Texas, United States, 75039
Actively Recruiting
15
NEXT Oncology /ID# 243007
San Antonio, Texas, United States, 78229
Actively Recruiting
16
South Texas Accelerated Research Therapeutics (START) /ID# 276268
San Antonio, Texas, United States, 78229
Actively Recruiting
17
Start Mountain Region /ID# 276270
West Valley City, Utah, United States, 84119
Actively Recruiting
18
Virginia Cancer Specialists - Fairfax /ID# 232592
Fairfax, Virginia, United States, 22031
Actively Recruiting
19
Tom Baker Cancer Centre /ID# 276206
Calgary, Alberta, Canada, T2N 4N2
Actively Recruiting
20
Princess Margaret Cancer Centre /ID# 276275
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
21
Shamir Medical Center /ID# 276238
Beer Ya'akov, Central District, Israel, 70300
Actively Recruiting
22
Meir Medical Center /ID# 277327
Kfar Saba, Central District, Israel, 4428164
Actively Recruiting
23
The Chaim Sheba Medical Center /ID# 238332
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
24
Tel Aviv Sourasky Medical Center /ID# 276591
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
25
Rambam Health Care Campus /ID# 238333
Haifa, Israel, 3109601
Actively Recruiting
26
Shaare Zedek Medical Center /ID# 276244
Jerusalem, Israel, 9103102
Actively Recruiting
27
Hadassah Medical Center-Hebrew University /ID# 252287
Jerusalem, Israel, 91120
Actively Recruiting
28
Rabin Medical Center. /ID# 250497
Petah Tikva, Israel, 4941492
Actively Recruiting
29
Aichi Cancer Center Hospital /ID# 250405
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
30
National Cancer Center Hospital East /ID# 238840
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
31
Kobe University Hospital /ID# 250409
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
32
Kansai Medical University Hospital /ID# 276805
Hirakata-shi, Osaka, Japan, 573-1191
Actively Recruiting
33
Shizuoka Cancer Center /ID# 250408
Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
34
National Cancer Center Hospital /ID# 238372
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
35
Wakayama Medical University Hospital /ID# 276806
Wakayama, Wakayama, Japan, 641-8510
Completed
36
National Cancer Center /ID# 252290
Goyang-si, Gyeonggido, South Korea, 10408
Actively Recruiting
37
CHA Bundang Medical Center /ID# 252291
Seongnam, Gyeonggido, South Korea, 13496
Actively Recruiting
38
Yonsei University Health System Severance Hospital /ID# 252288
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
39
Asan Medical Center /ID# 252289
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
40
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
Seoul, Seoul Teugbyeolsi, South Korea, 06591
Actively Recruiting
41
National Taiwan University Hospital /ID# 251894
Taipei City, Taipei, Taiwan, 100
Actively Recruiting
42
Taipei Medical University Shuang Ho Hospital /ID# 252449
New Taipei City, Taiwan, 23561
Actively Recruiting
43
National Cheng Kung University Hospital /ID# 252262
Tainan, Taiwan, 704
Actively Recruiting
44
Taipei Medical University Hospital /ID# 252450
Taipei, Taiwan, 11031
Actively Recruiting
45
Tri-Service General Hospital /ID# 252263
Taipei, Taiwan, 11490
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
17
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