Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab

Last updated: October 27, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatic Cancer

Ovarian Cysts

Digestive System Neoplasms

Treatment

Bevacizumab

Budigalimab

Azirkitug

Clinical Study ID

NCT05005403
M21-410
2021-002715-65
  • Ages > 18
  • All Genders

Study 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 (ABBV-514) as a monotherapy and in combination with Budigalimab or Bevacizumab,.

Bevacizumab is an approved product, while Budigalimab and Azirkitug (ABBV-514) 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 (ABBV-514) will be explored. Each treatment arm receives a different dose of Azirkitug (ABBV-514) in monotherapy and in combination with Budigalimab or Bevacizumab. Approximately 512 adult participants will be enrolled in the study across approximately 80 sites worldwide.

Participants will receive Azirkitug (ABBV-514) as a monotherapy or in combination with Budigalimab or Bevacizumab 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

Inclusion

Inclusion Criteria:

  • Pre Treatment biopsy or archive tissue within 6 months without intervening treatment

  • Eastern Cooperative Oncology Group (ECOG) performance status of <=1

  • 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) includingchemotherapy 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 ormetastatic setting.

  • Micro Satellite Stable Colorectal Cancer (MSS-CRC) - Progressed on Oxaliplatin,Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102,Regorafenib and not MSI-h or MMR-deficient

  • Gastric and Gastroesophageal Junction adenocarcinoma (GEA) - Advanced/metastaticprogressed on at least 1 prior cytotoxic chemotherapeutic regimen and if applicableimmune 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 surgicalresection. 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 systemic therapy thatmust have included taxane and treatment naïve to immunotherapy targeting T-cellco-stimulation

Exclusion

Exclusion Criteria:

  • Pancreatic Ductal Adenocarcinoma (PDAC) - Excludes neuroendocrine or acinarpancreatic carcinoma and participants with coagulopathy or at risk of or history ofDeep 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 deathprotein 1(PD-1)/Programmed cell death ligand 1 (PD-L1) who had immune mediatedtoxicity G3 or greater, interstitial lung disease, or hypersensitivity Combinationtreatment 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 Design

Total Participants: 512
Treatment Group(s): 4
Primary Treatment: Bevacizumab
Phase: 1
Study Start date:
November 01, 2021
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • The Chaim Sheba Medical Center /ID# 238332

    Ramat Gan 293788, Tel Aviv 293396 5265601
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 238332

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Hadassah Medical Center /ID# 252287

    Jerusalem, Yerushalayim 9112001
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 250497

    Haifa, 4941492
    Israel

    Site Not Available

  • Rambam Health Care Campus /ID# 238333

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus /ID# 238333

    Haifa 294801, 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 252287

    Jerusalem, 91120
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 252287

    Jerusalem 281184, 91120
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 250497

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 250497

    Petah Tikva 293918, 4941492
    Israel

    Active - Recruiting

  • Aichi Cancer Center Hospital /ID# 250405

    Nagoya-shi, Aichi 464-8681
    Japan

    Site Not Available

  • Aichi Cancer Center Hospital /ID# 250405

    Nagoya 1856057, Aichi-ken 1865694 464-8681
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East /ID# 238840

    Kashiwa-shi, Chiba 2113014 277-8577
    Japan

    Active - Recruiting

  • Kobe University Hospital /ID# 250409

    Kobe, Hyogo 650-0017
    Japan

    Site Not Available

  • Kobe University Hospital /ID# 250409

    Kobe-shi, Hyogo 650-0017
    Japan

    Site Not Available

  • Kobe University Hospital /ID# 250409

    Kobe 1859171, Hyōgo 1862047 650-0017
    Japan

    Active - Recruiting

  • Kansai Medical University Hirakata Hospital /ID# 276805

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital /ID# 276805

    Hirakata-shi, Osaka 1853904 573-1191
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center /ID# 250408

    Sunto-gun, Shizuoka 1851715 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital /ID# 238372

    Chuo-ku, Tokyo 1850144 104-0045
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital /ID# 276806

    Wakayama 1926004, Wakayama 1848938 641-8510
    Japan

    Active - Recruiting

  • National Cancer Center /ID# 252290

    Goyang, Gyeonggido 10408
    Korea, Republic of

    Site Not Available

  • National Cancer Center /ID# 252290

    Goyang-si, Gyeonggido 10408
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center /ID# 252291

    Seongnam, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center /ID# 252291

    Seongnam City, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • CHA bundang medical center CHA University /ID# 252291

    Seongnam-si, Gyeonggido 13496
    Korea, Republic of

    Site Not Available

  • Asan Medical Center /ID# 252289

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System /ID# 252288

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 252867

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Health System Severance Hospital /ID# 252288

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • National Cancer Center /ID# 252290

    Goyang-si 1842485, Gyeonggido 10408
    South Korea

    Active - Recruiting

  • CHA Bundang Medical Center /ID# 252291

    Seongnam 6876792, Gyeonggido 13496
    South Korea

    Active - Recruiting

  • Asan Medical Center /ID# 252289

    Seoul 1835848, Seoul Teugbyeolsi 05505
    South Korea

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867

    Seoul 1835848, Seoul Teugbyeolsi 06591
    South Korea

    Active - Recruiting

  • Yonsei University Health System Severance Hospital /ID# 252288

    Seoul 1835848, Seoul Teugbyeolsi 03722
    South Korea

    Active - Recruiting

  • National Taiwan University Hospital /ID# 251894

    Taipei City, Taipei 7280290 100
    Taiwan

    Active - Recruiting

  • Taipei Medical University Shuang Ho Hospital /ID# 252449

    New Taipei City, 23561
    Taiwan

    Site Not Available

  • Taipei Medical University Shuang Ho Hospital /ID# 252449

    New Taipei City 12908892, 23561
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital /ID# 252262

    Tainan, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital /ID# 252262

    Tainan City 1668355, 704
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital /ID# 252450

    Taipei 1668341, 11031
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital /ID# 252263

    Taipei 1668341, 11490
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital /ID# 252450

    Taipei City, 11031
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital /ID# 252263

    Taipei City, 11490
    Taiwan

    Active - Recruiting

  • Providence Medical Foundation /ID# 247453

    Fullerton, California 92835
    United States

    Site Not Available

  • City of Hope National Medical Center /ID# 276272

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Miami Cancer Institute Baptist Health South Florida /ID# 232599

    Miami, Florida 33176
    United States

    Site Not Available

  • The University of Chicago Medical Center /ID# 248394

    Chicago, Illinois 60637-1443
    United States

    Site Not Available

  • University of Illinois at Chicago /ID# 251750

    Chicago, Illinois 60607
    United States

    Site Not Available

  • University of Illinois Hospital and Health Sciences System /ID# 251750

    Chicago 4887398, Illinois 4896861 60607
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology /ID# 232593

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Community Health Network, Inc. /ID# 243011

    Indianapolis, Indiana 46250-2042
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593

    Fort Wayne 4920423, Indiana 4921868 46804
    United States

    Active - Recruiting

  • Community Health Network, Inc. /ID# 243011

    Indianapolis 4259418, Indiana 4921868 46250-2042
    United States

    Active - Recruiting

  • Norton Cancer Institute /ID# 248903

    Louisville, Kentucky 40241-2832
    United States

    Site Not Available

  • Norton Cancer Institute /ID# 248903

    Louisville 4299276, Kentucky 6254925 40241-2832
    United States

    Active - Recruiting

  • START Midwest /ID# 248685

    Grand Rapids 4994358, Michigan 5001836 49546-7062
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Onc/Hematology West PC dba Nebraska Cancer Specialists /ID# 247399

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399

    Omaha 5074472, Nebraska 5073708 68130
    United States

    Active - Recruiting

  • Carolina BioOncology Institute /ID# 232597

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Carolina BioOncology Institute /ID# 232597

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Active - Recruiting

  • NEXT Oncology Austin /ID# 243005

    Austin, Texas 78705-1171
    United States

    Site Not Available

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center /ID# 270059

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology /ID# 243007

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT Oncology Austin /ID# 243005

    Austin 4671654, Texas 4736286 78705-1171
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center /ID# 270059

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • NEXT Oncology /ID# 243007

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) /ID# 276268

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Start Mountain Region /ID# 276270

    West Valley City 5784607, Utah 5549030 84119
    United States

    Active - Recruiting

  • Virginia Cancer Specialists - Fairfax /ID# 232592

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists - Fairfax /ID# 232592

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.