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NCT05005403RecruitingPhase 1

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 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

Source: ClinicalTrials.gov · Last updated 23 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
694 (estimated)
First submitted
12 Aug 2021
Start date
1 Nov 2021
Primary completion date
31 Jul 2027
Lead sponsor
AbbVie
NCT number
NCT05005403

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 694
  • From 1 Nov 2021 to the primary completion date, 31 Jul 2027
  • 48 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No major surgery within 28 days prior to dosing
  • 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
  • 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

Other illness

  • 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 active autoimmune/immunodeficiency disease with limited exceptions

Other

  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (48)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tom Baker Cancer Centre /ID# 276206
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Princess Margaret Cancer Centre /ID# 276275
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
Shamir Medical Center /ID# 276238
Coordinator of this site? Confirm its status
Beer Ya'akovIsraelRecruiting
Rambam Health Care Campus /ID# 238333
Coordinator of this site? Confirm its status
HaifaIsraelRecruiting
Shaare Zedek Medical Center /ID# 276244
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Hadassah Medical Center-Hebrew University /ID# 252287
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Meir Medical Center /ID# 277327
Coordinator of this site? Confirm its status
Kefar SavaIsraelRecruiting
Rabin Medical Center. /ID# 250497
Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
The Chaim Sheba Medical Center /ID# 238332
Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
Tel Aviv Sourasky Medical Center /ID# 276591
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
National Cancer Center Hospital /ID# 238372
Coordinator of this site? Confirm its status
Chuo-kuJapanRecruiting
Kansai Medical University Hospital /ID# 276805
Coordinator of this site? Confirm its status
Hirakata-shiJapanRecruiting
National Cancer Center Hospital East /ID# 238840
Coordinator of this site? Confirm its status
Kashiwa-shiJapanRecruiting
Kobe University Hospital /ID# 250409
Coordinator of this site? Confirm its status
KobeJapanRecruiting
Aichi Cancer Center Hospital /ID# 250405
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
Shizuoka Cancer Center /ID# 250408
Coordinator of this site? Confirm its status
Sunto-gunJapanRecruiting
Wakayama Medical University Hospital /ID# 276806
Coordinator of this site? Confirm its status
WakayamaJapanCompleted
National Cancer Center /ID# 252290
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaRecruiting
CHA Bundang Medical Center /ID# 252291
Coordinator of this site? Confirm its status
SeongnamSouth KoreaRecruiting
Yonsei University Health System Severance Hospital /ID# 252288
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Asan Medical Center /ID# 252289
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Taipei Medical University Shuang Ho Hospital /ID# 252449
Coordinator of this site? Confirm its status
New Taipei CityTaiwanRecruiting
National Cheng Kung University Hospital /ID# 252262
Coordinator of this site? Confirm its status
TainanTaiwanRecruiting
Tri-Service General Hospital /ID# 252263
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
National Taiwan University Hospital /ID# 251894
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
Taipei Medical University Hospital /ID# 252450
Coordinator of this site? Confirm its status
TaipeiTaiwanRecruiting
NEXT Oncology Austin /ID# 243005
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
University of Illinois Hospital and Health Sciences System /ID# 251750
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Chicago Medical Center /ID# 276271
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
City of Hope National Medical Center /ID# 276272
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
Duke Cancer Institute /ID# 276267
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting
Virginia Cancer Specialists - Fairfax /ID# 232592
Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Coordinator of this site? Confirm its status
Fort WayneUnited StatesRecruiting
START Midwest /ID# 248685
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center /ID# 270059
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Carolina BioOncology Institute /ID# 232597
Coordinator of this site? Confirm its status
HuntersvilleUnited StatesRecruiting
Community Health Network, Inc. /ID# 243011
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
Coordinator of this site? Confirm its status
IrvineUnited StatesRecruiting
Next Oncology Dallas /ID# 276254
Coordinator of this site? Confirm its status
IrvingUnited StatesRecruiting
USC Norris Comprehensive Cancer Center /ID# 279603
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Norton Cancer Institute /ID# 248903
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
NEXT Oncology /ID# 243007
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
South Texas Accelerated Research Therapeutics (START) /ID# 276268
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Start Mountain Region /ID# 276270
Coordinator of this site? Confirm its status
West Valley CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.