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

May 11, 2026 updated by: AbbVie

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

694

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre /ID# 276206
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre /ID# 276275
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus /ID# 238333
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Center-Hebrew University /ID# 252287
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center /ID# 276244
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center. /ID# 250497
    • Central District
      • Beer Ya'akov, Central District, Israel, 70300
        • Recruiting
        • Shamir Medical Center /ID# 276238
      • Kfar Saba, Central District, Israel, 4428164
        • Recruiting
        • Meir Medical Center /ID# 277327
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center /ID# 238332
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 276591
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center Hospital /ID# 250405
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East /ID# 238840
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital /ID# 250409
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital /ID# 276805
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center /ID# 250408
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital /ID# 238372
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Completed
        • Wakayama Medical University Hospital /ID# 276806
  • South Korea
    • Gyeonggido
      • Goyang-si, Gyeonggido, South Korea, 10408
        • Recruiting
        • National Cancer Center /ID# 252290
      • Seongnam, Gyeonggido, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center /ID# 252291
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital /ID# 252288
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Recruiting
        • Asan Medical Center /ID# 252289
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
  • Taiwan
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Taipei Medical University Shuang Ho Hospital /ID# 252449
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital /ID# 252262
      • Taipei, Taiwan, 11031
        • Recruiting
        • Taipei Medical University Hospital /ID# 252450
      • Taipei, Taiwan, 11490
        • Recruiting
        • Tri-Service General Hospital /ID# 252263
    • Taipei
      • Taipei City, Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital /ID# 251894
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical Center /ID# 276272
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • University of Illinois Hospital and Health Sciences System /ID# 251750
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
      • Indianapolis, Indiana, United States, 46250-2042
        • Recruiting
        • Community Health Network, Inc. /ID# 243011
    • Kentucky
      • Louisville, Kentucky, United States, 40241-2832
        • Recruiting
        • Norton Cancer Institute /ID# 248903
    • Michigan
      • Grand Rapids, Michigan, United States, 49546-7062
        • Recruiting
        • START Midwest /ID# 248685
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute /ID# 276267
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolina BioOncology Institute /ID# 232597
        • Contact:
          • Site Coordinator
          • Phone Number: 844-663-3742
    • Texas
      • Austin, Texas, United States, 78705-1171
        • Recruiting
        • NEXT Oncology Austin /ID# 243005
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center /ID# 270059
      • Irving, Texas, United States, 75039
        • Recruiting
        • Next Oncology - Irving /ID# 276254
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology /ID# 243007
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics (START) /ID# 276268
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • Start Mountain Region /ID# 276270
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists - Fairfax /ID# 232592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Dose Escalation: Azirkitug
Participants will receive Azirkitug.
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 1 Dose Escalation: Azirkitug + Budigalimab
Participants will receive Azirkitug in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 2 Dose Expansion: Azirkitug
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 2 Dose Expansion: Azirkitug + Budigalimab
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 3 Dose Expansion: Azirkitug + Budigalimab
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 4 Dose Expansion: Azirkitug
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 4 Dose Expansion: Azirkitug + Budigalimab
Participants will receive Azirkitug in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 4 Dose Optimization and Randomization: Azirkitug
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab
Participants will receive Azirkitug in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 5 Dose Expansion: Azirkitug + Budigalimab
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 6 Dose Expansion: Azirkitug + Budigalimab
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 7 Dose Expansion: Azirkitug + Budigalimab
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 8 Safety Lead In: Azirkitug + Bevacizumab
Participants will receive Azirkitug in combination with bevacizumab.
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Drug: Bevacizumab
Intravenous (IV) Infusion
Experimental: Part 8 Dose Expansion: Azirkitug + Bevacizumab
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab.
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Drug: Bevacizumab
Intravenous (IV) Infusion
Experimental: Part 9 Dose Expansion: Azirkitug + Budigalimab
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Drug: Budigalimab
Intravenous (IV) Infusion
Other Names:
  • ABBV-181
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan
Participants will receive Azirkitug in combination with telisotuzumab adizutecan.
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514
Experimental: Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan
Participants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan.
Drug: Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Drug: Azirkitug
Intravenous (IV) Infusion
Other Names:
  • ABBV-514

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of Azirkitug
Time Frame: Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of azirkitug.
Up to 2 Years
Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug
Time Frame: Up to 2 Years
Time to maximum Observed Serum Concentration (Tmax) of azirkitug.
Up to 2 Years
Terminal Elimination Half-Life (t1/2) of Azirkitug
Time Frame: Up to 2 Years
Terminal elimination half-life (t1/2) of azirkitug.
Up to 2 Years
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.
Up to 2 Years
Azirkitug Antidrug Antibody (ADA)
Time Frame: Up to 2 Years
Incidence and concentration of azirkitug anti-drug antibodies.
Up to 2 Years
Azirkitug Neutralizing Antidrug Antibody (nADA)
Time Frame: Up to 2 Years
Incidence and concentration of azirkitug neutralizing anti-drug antibodies.
Up to 2 Years
Cmax of Budigalimab
Time Frame: Up to 2 Years
Cmax of budigalimab.
Up to 2 Years
Tmax of Budigalimab
Time Frame: Up to 2 Years
Tmax of budigalimab.
Up to 2 Years
t1/2 of Budigalimab
Time Frame: Up to 2 Years
t1/2 of budigalimab.
Up to 2 Years
AUC of Budigalimab
Time Frame: Up to 2 Years
AUC of budigalimab.
Up to 2 Years
Budigalimab ADA
Time Frame: Up to 2 Years
Incidence and concentration of budigalimab ADA.
Up to 2 Years
Budigalimab nADA
Time Frame: Up to 2 Years
Incidence and concentration of budigalimab nADA.
Up to 2 Years
Cmax of Telisotuzumab Adizutecan
Time Frame: Up to 2 Years
Cmax of telisotuzumab adizutecan.
Up to 2 Years
Tmax of Telisotuzumab Adizutecan
Time Frame: Up to 2 Years
Tmax of telisotuzumab adizutecan.
Up to 2 Years
t1/2 of Telisotuzumab Adizutecan
Time Frame: Up to 2 Years
t1/2 of telisotuzumab adizutecan.
Up to 2 Years
AUC of Telisotuzumab Adizutecan
Time Frame: Up to 2 Years
AUC of telisotuzumab adizutecan.
Up to 2 Years
Telisotuzumab Adizutecan ADA
Time Frame: Up to 2 Years
Incidence and concentration of telisotuzumab adizutecan ADA.
Up to 2 Years
Telisotuzumab Adizutecan nADA
Time Frame: Up to 2 Years
Incidence and concentration of telisotuzumab adizutecan nADA.
Up to 2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-410
  • 2021-002715-65 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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