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
Public ClinicalTrials.gov record NCT05005403. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05005403
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 694 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2021 (Actual)
- Primary completion
- Jul 2027 (Estimated)
- Completion
- Jul 2027 (Estimated)
- Last update posted
- Jun 23, 2026
2021 – 2027
United States locations
- U.S. sites
- 20
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center /ID# 276272 | Duarte | California | 91010 | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589 | Irvine | California | 92618 | Recruiting |
| USC Norris Comprehensive Cancer Center /ID# 279603 | Los Angeles | California | 90033 | 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 |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593 | Fort Wayne | Indiana | 46804 | Recruiting |
| Community Health Network, Inc. /ID# 243011 | Indianapolis | Indiana | 46250-2042 | Recruiting |
| Norton Cancer Institute /ID# 248903 | Louisville | Kentucky | 40241-2832 | Recruiting |
| START Midwest /ID# 248685 | Grand Rapids | Michigan | 49546-7062 | 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 |
| Duke Cancer Institute /ID# 276267 | Durham | North Carolina | 27710 | Recruiting |
| Carolina BioOncology Institute /ID# 232597 | Huntersville | North Carolina | 28078 | Recruiting |
| NEXT Oncology Austin /ID# 243005 | Austin | Texas | 78705-1171 | Recruiting |
| The University of Texas MD Anderson Cancer Center /ID# 270059 | Houston | Texas | 77030 | Recruiting |
| Next Oncology Dallas /ID# 276254 | Irving | Texas | 75039 | 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 | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 232592 | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05005403, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05005403 live on ClinicalTrials.gov.