OncoMatch/Clinical Trials/NCT05005403
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
Is NCT05005403 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Azirkitug and Budigalimab for non-small cell lung cancer.
Treatment: Azirkitug · Budigalimab · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Gastric Cancer
Esophageal Carcinoma
Ovarian Cancer
Pancreatic Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Allowed: EGFR any tested
Actionable gene alterations are eligible if failed targeted therapeutic options.
Disease stage
Required: Stage IV
Metastatic disease required
Advanced or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — standard of care
progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination)
Must have received: anti-PD-1 therapy — standard of care
progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination)
Must have received: platinum-based chemotherapy — recurrent or metastatic
progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting
Must have received: anti-PD-1 therapy — recurrent or metastatic
progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting
Must have received: oxaliplatin
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: irinotecan
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: antimetabolite (fluoropyrimidine)
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: EGFR inhibitor
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: VEGF inhibitor
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: VEGFR inhibitor
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: TAS-102
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: regorafenib
Progressed on Oxaliplatin, Irinotecan, a fluoropyrimidine, anti-EGFR, VEGF or VEGFR therapies, TAS-102, Regorafenib
Must have received: cytotoxic chemotherapy
progressed on at least 1 prior cytotoxic chemotherapeutic regimen
Must have received: immune checkpoint inhibitor
if applicable immune checkpoint inhibitor
Must have received: HER2-targeted therapy
if applicable ... HER2 therapy
Must have received: platinum-based chemotherapy
post SOC ... Platinum resistant cannot have >5 lines of prior therapy
Must have received: chemotherapy
progressed after SOC
Must have received: taxane
Progressed after >1 systemic therapy that must have included taxane
Cannot have received: immunotherapy targeting T-cell co-stimulation
treatment naïve to immunotherapy targeting T-cell co-stimulation
Cannot have received: anticancer therapy
anticancer therapy within 5 half-live or 28 days (whichever is shorter)
Cannot have received: agent targeting Chemokine Receptor (CCR)8
agent targeting Chemokine Receptor (CCR)8
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center /ID# 276272 · Duarte, California
- University of Illinois Hospital and Health Sciences System /ID# 251750 · Chicago, Illinois
- Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593 · Fort Wayne, Indiana
- Community Health Network, Inc. /ID# 243011 · Indianapolis, Indiana
- Norton Cancer Institute /ID# 248903 · Louisville, Kentucky
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05005403 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy targeting T-cell co-stimulation, anticancer therapy, agent targeting Chemokine Receptor (CCR)8 disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify