Non-Small Cell Lung CancerPhase 1NCT05005403
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
A Phase 1 study testing Azirkitug, Budigalimab and Bevacizumab in people with Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, run by AbbVie at 48 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer
- What is being tested?
- Azirkitug, Budigalimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 694 participants
- Where
- 48 sitesin 6 countries
- Study dates
- 1 Nov 2021to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre Treatment biopsy or archive tissue within 6 months without intervening treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 0 or 1 and a life expectancy of >= 3 months.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
- Laboratory values meeting criteria outlined in the protocol
- NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.
- HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting.
Show all 11Show fewer
- Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, TAS-102, Regorafenib and not MSI-h or MMR-deficient
- Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced/metastatic progressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicable immune checkpoint inhibitor and/or HER2 therapy
- High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection. Platinum resistant cannot have >5 lines of prior therapy.
- Pancreatic Adenocarcinoma (PDAC) - Advanced/metastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.
- Triple Negative Breast Cancer (TNBC) - Progressed after 1 or 2 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation
Who cannot join
- Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)/PE
- No major surgery within 28 days prior to dosing
- No active autoimmune/immunodeficiency disease with limited exceptions
- Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and/or events
- Pregnancy
- Excluded medications include anticancer therapy within 5 half-live or 28 days (whichever is shorter), agent targeting Chemokine Receptor (CCR)8, live vaccines, immunosuppressive medication with limited exceptions
Trial locations and contacts
48 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
48 sites in 6 countries
United States20 sites, 20 recruiting
- Recruiting
NEXT Oncology Austin /ID# 243005
Austin, Texas, 78705-1171
- Recruiting
University of Illinois Hospital and Health Sciences System /ID# 251750
Chicago, Illinois, 60607
- Recruiting
University of Chicago Medical Center /ID# 276271
Chicago, Illinois, 60637
- Recruiting
City of Hope National Medical Center /ID# 276272
Duarte, California, 91010
- Recruiting
Duke Cancer Institute /ID# 276267
Durham, North Carolina, 27710
- Recruiting
Virginia Cancer Specialists - Fairfax /ID# 232592
Fairfax, Virginia, 22031
- Recruiting
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Fort Wayne, Indiana, 46804
- Recruiting
START Midwest /ID# 248685
Grand Rapids, Michigan, 49546-7062
- Recruiting
The University of Texas MD Anderson Cancer Center /ID# 270059
Houston, Texas, 77030
- Recruiting
Carolina BioOncology Institute /ID# 232597
Huntersville, North Carolina, 28078
Site Coordinator, 844-663-3742
- Recruiting
Community Health Network, Inc. /ID# 243011
Indianapolis, Indiana, 46250-2042
- Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
Irvine, California, 92618
- Recruiting
Next Oncology Dallas /ID# 276254
Irving, Texas, 75039
- Recruiting
USC Norris Comprehensive Cancer Center /ID# 279603
Los Angeles, California, 90033
- Recruiting
Norton Cancer Institute /ID# 248903
Louisville, Kentucky, 40241-2832
- Recruiting
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
Minneapolis, Minnesota, 55455
- Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Omaha, Nebraska, 68130
- Recruiting
NEXT Oncology /ID# 243007
San Antonio, Texas, 78229
- Recruiting
South Texas Accelerated Research Therapeutics (START) /ID# 276268
San Antonio, Texas, 78229
- Recruiting
Start Mountain Region /ID# 276270
West Valley City, Utah, 84119
Israel8 sites, 8 recruiting
- Recruiting
Shamir Medical Center /ID# 276238
Beer Ya'akov, Central District, 70300
- Recruiting
Rambam Health Care Campus /ID# 238333
Haifa, 3109601
- Recruiting
Shaare Zedek Medical Center /ID# 276244
Jerusalem, 9103102
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 252287
Jerusalem, 91120
- Recruiting
Meir Medical Center /ID# 277327
Kefar Sava, Central District, 4428164
- Recruiting
Rabin Medical Center. /ID# 250497
Petah Tikva, Central District, 4941492
- Recruiting
The Chaim Sheba Medical Center /ID# 238332
Ramat Gan, Tel Aviv, 5265601
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 276591
Tel Aviv, Tel Aviv, 6423906
Japan7 sites, 6 recruiting
- Recruiting
National Cancer Center Hospital /ID# 238372
Chuo-ku, Tokyo, 104-0045
- Recruiting
Kansai Medical University Hospital /ID# 276805
Hirakata-shi, Osaka, 573-1191
- Recruiting
National Cancer Center Hospital East /ID# 238840
Kashiwa-shi, Chiba, 277-8577
- Recruiting
Kobe University Hospital /ID# 250409
Kobe, Hyōgo, 650-0017
- Recruiting
Aichi Cancer Center Hospital /ID# 250405
Nagoya, Aichi-ken, 464-8681
- Recruiting
Shizuoka Cancer Center /ID# 250408
Sunto-gun, Shizuoka, 411-8777
- Completed
Wakayama Medical University Hospital /ID# 276806
Wakayama, Wakayama, 641-8510
South Korea5 sites, 5 recruiting
- Recruiting
National Cancer Center /ID# 252290
Goyang-si, Gyeonggido, 10408
- Recruiting
CHA Bundang Medical Center /ID# 252291
Seongnam, Gyeonggido, 13496
- Recruiting
Yonsei University Health System Severance Hospital /ID# 252288
Seoul, Seoul Teugbyeolsi, 03722
- Recruiting
Asan Medical Center /ID# 252289
Seoul, Seoul Teugbyeolsi, 05505
- Recruiting
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
Seoul, Seoul Teugbyeolsi, 06591
Taiwan5 sites, 5 recruiting
- Recruiting
Taipei Medical University Shuang Ho Hospital /ID# 252449
New Taipei City, 23561
- Recruiting
National Cheng Kung University Hospital /ID# 252262
Tainan, 704
- Recruiting
National Taiwan University Hospital /ID# 251894
Taipei, 100
- Recruiting
Taipei Medical University Hospital /ID# 252450
Taipei, 11031
- Recruiting
Tri-Service General Hospital /ID# 252263
Taipei, 11490
Canada3 sites, 3 recruiting
- Recruiting
Tom Baker Cancer Centre /ID# 276206
Calgary, Alberta, T2N 4N2
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274
Montreal, Quebec, H2X 0C1
- Recruiting
Princess Margaret Cancer Centre /ID# 276275
Toronto, Ontario, M5G 2M9
About this study
Official title: 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
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.
Read more
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
- Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer
- Being tested
- Azirkitug, Budigalimab, Bevacizumab, Telisotuzumab Adizutecan
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Head and Neck Squamous Cell Carcinoma, HNSCC, Solid Tumors, Budigalimab, ABBV-181, ABBV-514, Micro Satellite Stable Colorectal Cancer, MSS-CRC, Gastric Cancer, Esophageal Cancer, GEA, GEJ, High-Grade Serous Ovarian Cancer, HGSOC, Pancreatic Cancer, PDAC, Triple Negative Breast Cancer, TNBC, Telisotuzumab Adizutecan, ABBV-400
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Esophageal Neoplasms, Pancreatic Neoplasms, Triple Negative Breast Neoplasms, Stomach Neoplasms, Anophthalmia with pulmonary hypoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzirkitugDrug
Intravenous (IV) Infusion
BudigalimabDrug
Intravenous (IV) Infusion
BevacizumabDrug
Intravenous (IV) Infusion
Telisotuzumab AdizutecanDrug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation: Azirkitug | Experimental | Participants will receive Azirkitug. Receives: Drug: Azirkitug |
| Part 1 Dose Escalation: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 2 Dose Expansion: Azirkitug | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. Receives: Drug: Azirkitug |
| Part 2 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 3 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 4 Dose Expansion: Azirkitug | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. Receives: Drug: Azirkitug |
| Part 4 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 4 Dose Optimization and Randomization: Azirkitug | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. Receives: Drug: Azirkitug |
| Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab | Experimental | Participants will receive Azirkitug in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 5 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 6 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 7 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 8 Safety Lead In: Azirkitug + Bevacizumab | Experimental | Participants will receive Azirkitug in combination with bevacizumab. Receives: Drug: Azirkitug; Drug: Bevacizumab |
| Part 8 Dose Expansion: Azirkitug + Bevacizumab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab. Receives: Drug: Azirkitug; Drug: Bevacizumab |
| Part 9 Dose Expansion: Azirkitug + Budigalimab | Experimental | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. Receives: Drug: Azirkitug; Drug: Budigalimab |
| Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan | Experimental | Participants will receive Azirkitug in combination with telisotuzumab adizutecan. Receives: Drug: Azirkitug; Drug: Telisotuzumab Adizutecan |
| Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan | Experimental | Participants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan. Receives: Drug: Azirkitug; Drug: Telisotuzumab Adizutecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of Azirkitug
Maximum Observed Serum Concentration (Cmax) of azirkitug.
Measured: Up to 2 Years
Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug
Time to maximum Observed Serum Concentration (Tmax) of azirkitug.
Measured: Up to 2 Years
Terminal Elimination Half-Life (t1/2) of Azirkitug
Terminal elimination half-life (t1/2) of azirkitug.
Measured: 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.
Measured: Up to 2 Years
Azirkitug Antidrug Antibody (ADA)
Incidence and concentration of azirkitug anti-drug antibodies.
Measured: Up to 2 Years
Azirkitug Neutralizing Antidrug Antibody (nADA)
Incidence and concentration of azirkitug neutralizing anti-drug antibodies.
Measured: Up to 2 Years
Cmax of Budigalimab
Cmax of budigalimab.
Measured: Up to 2 Years
Tmax of Budigalimab
Tmax of budigalimab.
Measured: Up to 2 Years
t1/2 of Budigalimab
t1/2 of budigalimab.
Measured: Up to 2 Years
AUC of Budigalimab
AUC of budigalimab.
Measured: Up to 2 Years
Budigalimab ADA
Incidence and concentration of budigalimab ADA.
Measured: Up to 2 Years
Budigalimab nADA
Incidence and concentration of budigalimab nADA.
Measured: Up to 2 Years
Cmax of Telisotuzumab Adizutecan
Cmax of telisotuzumab adizutecan.
Measured: Up to 2 Years
Tmax of Telisotuzumab Adizutecan
Tmax of telisotuzumab adizutecan.
Measured: Up to 2 Years
t1/2 of Telisotuzumab Adizutecan
t1/2 of telisotuzumab adizutecan.
Measured: Up to 2 Years
AUC of Telisotuzumab Adizutecan
AUC of telisotuzumab adizutecan.
Measured: Up to 2 Years
Telisotuzumab Adizutecan ADA
Incidence and concentration of telisotuzumab adizutecan ADA.
Measured: Up to 2 Years
Telisotuzumab Adizutecan nADA
Incidence and concentration of telisotuzumab adizutecan nADA.
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Nov 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 694 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005403
- Sponsor's protocol ID
- M21-410
- Status last verified
- Jun 2026
- First submitted
- 12 Aug 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05005403
- Acronym / sponsor ID
- M21-410
- 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, Pancreatic Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Head and Neck Squamous Cell Carcinoma, HNSCC, Solid Tumors, Budigalimab, ABBV-181, ABBV-514
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 694 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation: Azirkitug | Experimental | Drug: AzirkitugParticipants will receive Azirkitug. |
| Part 1 Dose Escalation: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug in combination with budigalimab. |
| Part 2 Dose Expansion: Azirkitug | Experimental | Drug: AzirkitugParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
| Part 2 Dose Expansion: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 3 Dose Expansion: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 4 Dose Expansion: Azirkitug | Experimental | Drug: AzirkitugParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
| Part 4 Dose Expansion: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug in combination with budigalimab. |
| Part 4 Dose Optimization and Randomization: Azirkitug | Experimental | Drug: AzirkitugParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
| Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug in combination with budigalimab. |
| Part 5 Dose Expansion: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 6 Dose Expansion: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 7 Dose Expansion: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 8 Safety Lead In: Azirkitug + Bevacizumab | Experimental | Drug: Azirkitug, Drug: BevacizumabParticipants will receive Azirkitug in combination with bevacizumab. |
| Part 8 Dose Expansion: Azirkitug + Bevacizumab | Experimental | Drug: Azirkitug, Drug: BevacizumabParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab. |
| Part 9 Dose Expansion: Azirkitug + Budigalimab | Experimental | Drug: Azirkitug, Drug: BudigalimabParticipants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan | Experimental | Drug: Azirkitug, Drug: Telisotuzumab AdizutecanParticipants will receive Azirkitug in combination with telisotuzumab adizutecan. |
| Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan | Experimental | Drug: Azirkitug, Drug: Telisotuzumab AdizutecanParticipants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pre Treatment biopsy or archive tissue within 6 months without intervening treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 0 or 1 and a life expectancy of >= 3 months.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
- Laboratory values meeting criteria outlined in the protocol
- NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination). Actionable gene alterations are eligible if failed targeted therapeutic options.
Key exclusion criteria (6 listed)
- Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinar pancreatic carcinoma and participants with coagulopathy or at risk of or history of Deep vein thrombosis (DVT)/PE
- No major surgery within 28 days prior to dosing
- No active autoimmune/immunodeficiency disease with limited exceptions
- Combination treatment excludes participants treated with anti-programmed cell death protein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediated toxicity G3 or greater, interstitial lung disease, or hypersensitivity Combination treatment may also require no significant cardiac deficiencies and/or events
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzirkitugIntravenous (IV) Infusion | Drug | Part 1 Dose Escalation: Azirkitug, Part 1 Dose Escalation: Azirkitug + Budigalimab, Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan, Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan, Part 2 Dose Expansion: Azirkitug, Part 2 Dose Expansion: Azirkitug + Budigalimab, Part 3 Dose Expansion: Azirkitug + Budigalimab, Part 4 Dose Expansion: Azirkitug, Part 4 Dose Expansion: Azirkitug + Budigalimab, Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab, Part 4 Dose Optimization and Randomization: Azirkitug, Part 5 Dose Expansion: Azirkitug + Budigalimab, Part 6 Dose Expansion: Azirkitug + Budigalimab, Part 7 Dose Expansion: Azirkitug + Budigalimab, Part 8 Dose Expansion: Azirkitug + Bevacizumab, Part 8 Safety Lead In: Azirkitug + Bevacizumab, Part 9 Dose Expansion: Azirkitug + Budigalimab |
| BudigalimabIntravenous (IV) Infusion | Drug | Part 1 Dose Escalation: Azirkitug + Budigalimab, Part 2 Dose Expansion: Azirkitug + Budigalimab, Part 3 Dose Expansion: Azirkitug + Budigalimab, Part 4 Dose Expansion: Azirkitug + Budigalimab, Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab, Part 5 Dose Expansion: Azirkitug + Budigalimab, Part 6 Dose Expansion: Azirkitug + Budigalimab, Part 7 Dose Expansion: Azirkitug + Budigalimab, Part 9 Dose Expansion: Azirkitug + Budigalimab |
| BevacizumabIntravenous (IV) Infusion | Drug | Part 8 Dose Expansion: Azirkitug + Bevacizumab, Part 8 Safety Lead In: Azirkitug + Bevacizumab |
| Telisotuzumab AdizutecanIntravenous (IV) Infusion | Drug | Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan, Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan |
Primary outcome
Number of Participants with Adverse Events (AE)
Time frame: Up to 2 Years
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.
Maximum Observed Serum Concentration (Cmax) of Azirkitug
Time frame: Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of azirkitug.
Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug
Time frame: Up to 2 Years
Time to maximum Observed Serum Concentration (Tmax) of azirkitug.
Terminal Elimination Half-Life (t1/2) of Azirkitug
Time frame: Up to 2 Years
Terminal elimination half-life (t1/2) of azirkitug.
Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug
Time frame: Up to 2 Years
Area under the serum concentration versus time curve (AUC) of azirkitug.
Azirkitug Antidrug Antibody (ADA)
Time frame: Up to 2 Years
Incidence and concentration of azirkitug anti-drug antibodies.
Azirkitug Neutralizing Antidrug Antibody (nADA)
Time frame: Up to 2 Years
Incidence and concentration of azirkitug neutralizing anti-drug antibodies.
Cmax of Budigalimab
Time frame: Up to 2 Years
Cmax of budigalimab.
Tmax of Budigalimab
Time frame: Up to 2 Years
Tmax of budigalimab.
t1/2 of Budigalimab
Time frame: Up to 2 Years
t1/2 of budigalimab.
AUC of Budigalimab
Time frame: Up to 2 Years
AUC of budigalimab.
Budigalimab ADA
Time frame: Up to 2 Years
Incidence and concentration of budigalimab ADA.
Budigalimab nADA
Time frame: Up to 2 Years
Incidence and concentration of budigalimab nADA.
Cmax of Telisotuzumab Adizutecan
Time frame: Up to 2 Years
Cmax of telisotuzumab adizutecan.
Tmax of Telisotuzumab Adizutecan
Time frame: Up to 2 Years
Tmax of telisotuzumab adizutecan.
t1/2 of Telisotuzumab Adizutecan
Time frame: Up to 2 Years
t1/2 of telisotuzumab adizutecan.
AUC of Telisotuzumab Adizutecan
Time frame: Up to 2 Years
AUC of telisotuzumab adizutecan.
Telisotuzumab Adizutecan ADA
Time frame: Up to 2 Years
Incidence and concentration of telisotuzumab adizutecan ADA.
Telisotuzumab Adizutecan nADA
Time frame: Up to 2 Years
Incidence and concentration of telisotuzumab adizutecan nADA.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
48 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azirkitug, Budigalimab and Bevacizumab in people with Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma, run by AbbVie at 48 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Israel, Japan, South Korea, Taiwan and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AE) (time frame: Up to 2 Years). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.