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 now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05005403

Run by

AbbVie

People needed

694

Starts

2021-11-01

Expected to finish

2027-07-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tri-Service General Hospital /ID# 252263 — Taipei, Taiwan (enrolling)
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589 — Irvine, California, United States (enrolling)
• USC Norris Comprehensive Cancer Center /ID# 279603 — Los Angeles, California, United States (enrolling)
• University of Illinois Hospital and Health Sciences System /ID# 251750 — Chicago, Illinois, United States (enrolling)
• University of Chicago Medical Center /ID# 276271 — Chicago, Illinois, United States (enrolling)
• Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593 — Fort Wayne, Indiana, United States (enrolling)
• Community Health Network, Inc. /ID# 243011 — Indianapolis, Indiana, United States (enrolling)
• Norton Cancer Institute /ID# 248903 — Louisville, Kentucky, United States (enrolling)
• START Midwest /ID# 248685 — Grand Rapids, Michigan, United States (enrolling)
• M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200 — Minneapolis, Minnesota, United States (enrolling)
• Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399 — Omaha, Nebraska, United States (enrolling)
• Duke Cancer Institute /ID# 276267 — Durham, North Carolina, United States (enrolling)
• Carolina BioOncology Institute /ID# 232597 — Huntersville, North Carolina, United States (enrolling)
• NEXT Oncology Austin /ID# 243005 — Austin, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center /ID# 270059 — Houston, Texas, United States (enrolling)
• Next Oncology Dallas /ID# 276254 — Irving, Texas, United States (enrolling)
• NEXT Oncology /ID# 243007 — San Antonio, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics (START) /ID# 276268 — San Antonio, Texas, United States (enrolling)
• Start Mountain Region /ID# 276270 — West Valley City, Utah, United States (enrolling)
• Virginia Cancer Specialists - Fairfax /ID# 232592 — Fairfax, Virginia, United States (enrolling)
• Tom Baker Cancer Centre /ID# 276206 — Calgary, Alberta, Canada (enrolling)
• Princess Margaret Cancer Centre /ID# 276275 — Toronto, Ontario, Canada (enrolling)
• Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274 — Montreal, Quebec, Canada (enrolling)
• Shamir Medical Center /ID# 276238 — Beer Ya'akov, Central District, Israel (enrolling)
• Meir Medical Center /ID# 277327 — Kefar Sava, Central District, Israel (enrolling)

Full record on ClinicalTrials.gov

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