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RecruitingInterventionalPhase 1

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

NCT ID: NCT05005403Sponsor: AbbVieLast updated: 2026-06-16

Summary

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.

Arms & interventions

  • DrugAzirkitug

    Intravenous (IV) Infusion

  • DrugBudigalimab

    Intravenous (IV) Infusion

  • DrugBevacizumab

    Intravenous (IV) Infusion

  • DrugTelisotuzumab Adizutecan

    Intravenous (IV) Infusion

Outcome measures

Primary

  • Number of Participants with Adverse Events (AE)

    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.

    Time frame: Up to 2 Years

  • Maximum Observed Serum Concentration (Cmax) of Azirkitug

    Maximum Observed Serum Concentration (Cmax) of azirkitug.

    Time frame: Up to 2 Years

  • Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug

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

    Time frame: Up to 2 Years

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

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

    Time frame: Up to 2 Years

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

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

    Time frame: Up to 2 Years

  • Azirkitug Antidrug Antibody (ADA)

    Incidence and concentration of azirkitug anti-drug antibodies.

    Time frame: Up to 2 Years

  • Azirkitug Neutralizing Antidrug Antibody (nADA)

    Incidence and concentration of azirkitug neutralizing anti-drug antibodies.

    Time frame: Up to 2 Years

  • Cmax of Budigalimab

    Cmax of budigalimab.

    Time frame: Up to 2 Years

  • Tmax of Budigalimab

    Tmax of budigalimab.

    Time frame: Up to 2 Years

  • t1/2 of Budigalimab

    t1/2 of budigalimab.

    Time frame: Up to 2 Years

  • AUC of Budigalimab

    AUC of budigalimab.

    Time frame: Up to 2 Years

  • Budigalimab ADA

    Incidence and concentration of budigalimab ADA.

    Time frame: Up to 2 Years

  • Budigalimab nADA

    Incidence and concentration of budigalimab nADA.

    Time frame: Up to 2 Years

  • Cmax of Telisotuzumab Adizutecan

    Cmax of telisotuzumab adizutecan.

    Time frame: Up to 2 Years

  • Tmax of Telisotuzumab Adizutecan

    Tmax of telisotuzumab adizutecan.

    Time frame: Up to 2 Years

  • t1/2 of Telisotuzumab Adizutecan

    t1/2 of telisotuzumab adizutecan.

    Time frame: Up to 2 Years

  • AUC of Telisotuzumab Adizutecan

    AUC of telisotuzumab adizutecan.

    Time frame: Up to 2 Years

  • Telisotuzumab Adizutecan ADA

    Incidence and concentration of telisotuzumab adizutecan ADA.

    Time frame: Up to 2 Years

  • Telisotuzumab Adizutecan nADA

    Incidence and concentration of telisotuzumab adizutecan nADA.

    Time frame: Up to 2 Years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (19)

City of Hope National Medical Center /ID# 276272

Duarte, California, 91010

Recruiting

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589

Irvine, California, 92618

Recruiting

USC Norris Comprehensive Cancer Center /ID# 279603

Los Angeles, California, 90033

Recruiting

University of Illinois Hospital and Health Sciences System /ID# 251750

Chicago, Illinois, 60607

Recruiting

Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593

Fort Wayne, Indiana, 46804

Recruiting

Community Health Network, Inc. /ID# 243011

Indianapolis, Indiana, 46250-2042

Recruiting

Norton Cancer Institute /ID# 248903

Louisville, Kentucky, 40241-2832

Recruiting

START Midwest /ID# 248685

Grand Rapids, Michigan, 49546-7062

Recruiting

M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200

Minneapolis, Minnesota, 55455

Recruiting

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399

Omaha, Nebraska, 68130

Recruiting

Duke Cancer Institute /ID# 276267

Durham, North Carolina, 27710

Recruiting

Carolina BioOncology Institute /ID# 232597

Huntersville, North Carolina, 28078

Recruiting
Site Coordinator · Contact

NEXT Oncology Austin /ID# 243005

Austin, Texas, 78705-1171

Recruiting

The University of Texas MD Anderson Cancer Center /ID# 270059

Houston, Texas, 77030

Recruiting

Next Oncology Dallas /ID# 276254

Irving, Texas, 75039

Recruiting

NEXT Oncology /ID# 243007

San Antonio, Texas, 78229

Recruiting

South Texas Accelerated Research Therapeutics (START) /ID# 276268

San Antonio, Texas, 78229

Recruiting

Start Mountain Region /ID# 276270

West Valley City, Utah, 84119

Recruiting

Virginia Cancer Specialists - Fairfax /ID# 232592

Fairfax, Virginia, 22031

Recruiting