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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.

Phase 1RecruitingAbbVieNCT05005403Data as of Jun 2026Location: International · 5 countries

Treatment: Azirkitug · Budigalimab · BevacizumabCancer 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Bevacizumab

Other

AzirkitugBudigalimab

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.

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