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NCT Number: 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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Anophthalmia with pulmonary hypoplasia Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Gastric/Esophageal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma High-grade Serous Ovarian Cancer Lung Diseases Lung Neoplasms Micro Satellite Stable Colorectal Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tom Baker Cancer Centre /ID# 276206, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Azirkitug

Drug

Intravenous (IV) Infusion

Budigalimab

Drug

Intravenous (IV) Infusion

Bevacizumab

Drug

Intravenous (IV) Infusion

Telisotuzumab Adizutecan

Drug

Intravenous (IV) Infusion

Primary outcomes

  1. Number of Participants with Adverse Events (AE)

    Time frame: 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.

  2. Maximum Observed Serum Concentration (Cmax) of Azirkitug

    Time frame: Up to 2 Years

    Maximum Observed Serum Concentration (Cmax) of azirkitug.

  3. Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug

    Time frame: Up to 2 Years

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

  4. Terminal Elimination Half-Life (t1/2) of Azirkitug

    Time frame: Up to 2 Years

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

  5. Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug

    Time frame: Up to 2 Years

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

  6. Azirkitug Antidrug Antibody (ADA)

    Time frame: Up to 2 Years

    Incidence and concentration of azirkitug anti-drug antibodies.

  7. Azirkitug Neutralizing Antidrug Antibody (nADA)

    Time frame: Up to 2 Years

    Incidence and concentration of azirkitug neutralizing anti-drug antibodies.

  8. Cmax of Budigalimab

    Time frame: Up to 2 Years

    Cmax of budigalimab.

  9. Tmax of Budigalimab

    Time frame: Up to 2 Years

    Tmax of budigalimab.

  10. t1/2 of Budigalimab

    Time frame: Up to 2 Years

    t1/2 of budigalimab.

  11. AUC of Budigalimab

    Time frame: Up to 2 Years

    AUC of budigalimab.

  12. Budigalimab ADA

    Time frame: Up to 2 Years

    Incidence and concentration of budigalimab ADA.

  13. Budigalimab nADA

    Time frame: Up to 2 Years

    Incidence and concentration of budigalimab nADA.

  14. Cmax of Telisotuzumab Adizutecan

    Time frame: Up to 2 Years

    Cmax of telisotuzumab adizutecan.

  15. Tmax of Telisotuzumab Adizutecan

    Time frame: Up to 2 Years

    Tmax of telisotuzumab adizutecan.

  16. t1/2 of Telisotuzumab Adizutecan

    Time frame: Up to 2 Years

    t1/2 of telisotuzumab adizutecan.

  17. AUC of Telisotuzumab Adizutecan

    Time frame: Up to 2 Years

    AUC of telisotuzumab adizutecan.

  18. Telisotuzumab Adizutecan ADA

    Time frame: Up to 2 Years

    Incidence and concentration of telisotuzumab adizutecan ADA.

  19. Telisotuzumab Adizutecan nADA

    Time frame: Up to 2 Years

    Incidence and concentration of telisotuzumab adizutecan nADA.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2021
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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