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Study of Azirkitug for Lung, Head and Neck, and Other Solid Cancers

This study is looking at a new drug called Azirkitug, by itself or with other treatments like Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan. It's for adults with certain advanced cancers, including Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), and other solid tumors. The main goals are to see how safe these treatments are (adverse events) and how the body handles Azirkitug (pharmacokinetics). To join, you need to be at least 18, have a recent biopsy, and your cancer must be measurable. This study aims to understand these new treatments better.

Study design
This interventional study plans to enroll 694 participants. Participants will be placed into groups to receive Azirkitug alone or in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and drug levels for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05005403

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~694 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:AzirkitugBudigalimabBevacizumabTelisotuzumab Adizutecan

At a glance

Recruiting sites
47 of 48 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AE)
Measured over Up to 2 Years
+18 more outcomes measured

Conditions

Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Micro Satellite Stable Colorectal Cancer
Gastric/Esophageal Cancer
High-Grade Serous Ovarian Cancer
Pancreatic Cancer
Triple Negative Breast Cancer

Explore related trials

Colorectal CarcinomaEsophageal CarcinomaGastric CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic CarcinomaSolid NeoplasmTriple-negative breast cancer

Where it's being run

48 sites across 27 states
Texas5
Taiwan5
California3
Central District3
Israel3
Seoul Teugbyeolsi3
Illinois2
Indiana2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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 major surgery within 28 days prior to dosing
No active autoimmune/immunodeficiency disease with limited exceptions
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
Pregnancy
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

What this trial measures

  • Number of Participants with Adverse Events (AE)Up to 2 Years

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  • Maximum Observed Serum Concentration (Cmax) of AzirkitugUp to 2 Years

    Maximum Observed Serum Concentration (Cmax) of azirkitug.

  • Time to Maximum Observed Serum Concentration (Tmax) of AzirkitugUp to 2 Years

    Time to maximum Observed Serum Concentration (Tmax) of azirkitug.

  • Terminal Elimination Half-Life (t1/2) of AzirkitugUp to 2 Years

    Terminal elimination half-life (t1/2) of azirkitug.

  • Area Under the Serum Concentration Versus Time Curve (AUC) of AzirkitugUp to 2 Years

    Area under the serum concentration versus time curve (AUC) of azirkitug.

  • Azirkitug Antidrug Antibody (ADA)Up to 2 Years

    Incidence and concentration of azirkitug anti-drug antibodies.

  • Azirkitug Neutralizing Antidrug Antibody (nADA)Up to 2 Years

    Incidence and concentration of azirkitug neutralizing anti-drug antibodies.

  • Cmax of BudigalimabUp to 2 Years

    Cmax of budigalimab.

  • Tmax of BudigalimabUp to 2 Years

    Tmax of budigalimab.

  • t1/2 of BudigalimabUp to 2 Years

    t1/2 of budigalimab.

  • AUC of BudigalimabUp to 2 Years

    AUC of budigalimab.

  • Budigalimab ADAUp to 2 Years

    Incidence and concentration of budigalimab ADA.

  • Budigalimab nADAUp to 2 Years

    Incidence and concentration of budigalimab nADA.

  • Cmax of Telisotuzumab AdizutecanUp to 2 Years

    Cmax of telisotuzumab adizutecan.

  • Tmax of Telisotuzumab AdizutecanUp to 2 Years

    Tmax of telisotuzumab adizutecan.

  • t1/2 of Telisotuzumab AdizutecanUp to 2 Years

    t1/2 of telisotuzumab adizutecan.

  • AUC of Telisotuzumab AdizutecanUp to 2 Years

    AUC of telisotuzumab adizutecan.

  • Telisotuzumab Adizutecan ADAUp to 2 Years

    Incidence and concentration of telisotuzumab adizutecan ADA.

  • Telisotuzumab Adizutecan nADAUp to 2 Years

    Incidence and concentration of telisotuzumab adizutecan nADA.