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
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- 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
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tom Baker Cancer Centre /ID# 276206 Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274 Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Princess Margaret Cancer Centre /ID# 276275 Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Shamir Medical Center /ID# 276238 Coordinator of this site? Confirm its status | Beer Ya'akov | Israel | Recruiting |
| Rambam Health Care Campus /ID# 238333 Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Shaare Zedek Medical Center /ID# 276244 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Hadassah Medical Center-Hebrew University /ID# 252287 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Meir Medical Center /ID# 277327 Coordinator of this site? Confirm its status | Kefar Sava | Israel | Recruiting |
| Rabin Medical Center. /ID# 250497 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 238332 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 276591 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| National Cancer Center Hospital /ID# 238372 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Recruiting |
| Kansai Medical University Hospital /ID# 276805 Coordinator of this site? Confirm its status | Hirakata-shi | Japan | Recruiting |
| National Cancer Center Hospital East /ID# 238840 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| Kobe University Hospital /ID# 250409 Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| Aichi Cancer Center Hospital /ID# 250405 Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Shizuoka Cancer Center /ID# 250408 Coordinator of this site? Confirm its status | Sunto-gun | Japan | Recruiting |
| Wakayama Medical University Hospital /ID# 276806 Coordinator of this site? Confirm its status | Wakayama | Japan | Completed |
| National Cancer Center /ID# 252290 Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| CHA Bundang Medical Center /ID# 252291 Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Yonsei University Health System Severance Hospital /ID# 252288 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center /ID# 252289 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Taipei Medical University Shuang Ho Hospital /ID# 252449 Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| National Cheng Kung University Hospital /ID# 252262 Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Tri-Service General Hospital /ID# 252263 Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital /ID# 251894 Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Medical University Hospital /ID# 252450 Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| NEXT Oncology Austin /ID# 243005 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| University of Illinois Hospital and Health Sciences System /ID# 251750 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Chicago Medical Center /ID# 276271 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| City of Hope National Medical Center /ID# 276272 Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Duke Cancer Institute /ID# 276267 Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 232592 Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593 Coordinator of this site? Confirm its status | Fort Wayne | United States | Recruiting |
| START Midwest /ID# 248685 Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center /ID# 270059 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Carolina BioOncology Institute /ID# 232597 Coordinator of this site? Confirm its status | Huntersville | United States | Recruiting |
| Community Health Network, Inc. /ID# 243011 Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589 Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Next Oncology Dallas /ID# 276254 Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
| USC Norris Comprehensive Cancer Center /ID# 279603 Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Norton Cancer Institute /ID# 248903 Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200 Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399 Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| NEXT Oncology /ID# 243007 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| South Texas Accelerated Research Therapeutics (START) /ID# 276268 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Start Mountain Region /ID# 276270 Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.