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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 (May 2026). This Phase 1 trial studies multiple treatments including Azirkitug and Budigalimab for non-small cell lung cancer.

Phase 1RecruitingAbbVieNCT05005403Data as of May 2026

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

Cancer type

Non-Small Cell Lung Carcinoma

Head and Neck Squamous Cell Carcinoma

Colorectal 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 →

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