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

NCT05005403
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
694
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Lead sponsor
AbbVie
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Start date
2021-11-01
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Number of sites
48
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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.
clinicaltrials.gov
Short title
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
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Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-07-01
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First posted
2021-08-13
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Registry last updated
2026-06-23
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Primary completion date
2027-07-01
clinicaltrials.gov
Start date
2021-11-01
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Participants
694
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Participant count basis
Estimated
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Planned participants
694
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Protocol amendments
7
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Number of sites
48
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05005403
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ClinicalTrials.gov ID
NCT05005403
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants with Adverse Events (AE)

    Timeframe: 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

    Timeframe: Up to 2 Years

    Maximum Observed Serum Concentration (Cmax) of azirkitug.

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

    Timeframe: Up to 2 Years

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

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

    Timeframe: Up to 2 Years

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

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

    Timeframe: Up to 2 Years

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

  6. Azirkitug Antidrug Antibody (ADA)

    Timeframe: Up to 2 Years

    Incidence and concentration of azirkitug anti-drug antibodies.

  7. Azirkitug Neutralizing Antidrug Antibody (nADA)

    Timeframe: Up to 2 Years

    Incidence and concentration of azirkitug neutralizing anti-drug antibodies.

  8. Cmax of Budigalimab

    Timeframe: Up to 2 Years

    Cmax of budigalimab.

  9. Tmax of Budigalimab

    Timeframe: Up to 2 Years

    Tmax of budigalimab.

  10. t1/2 of Budigalimab

    Timeframe: Up to 2 Years

    t1/2 of budigalimab.

  11. AUC of Budigalimab

    Timeframe: Up to 2 Years

    AUC of budigalimab.

  12. Budigalimab ADA

    Timeframe: Up to 2 Years

    Incidence and concentration of budigalimab ADA.

  13. Budigalimab nADA

    Timeframe: Up to 2 Years

    Incidence and concentration of budigalimab nADA.

  14. Cmax of Telisotuzumab Adizutecan

    Timeframe: Up to 2 Years

    Cmax of telisotuzumab adizutecan.

  15. Tmax of Telisotuzumab Adizutecan

    Timeframe: Up to 2 Years

    Tmax of telisotuzumab adizutecan.

  16. t1/2 of Telisotuzumab Adizutecan

    Timeframe: Up to 2 Years

    t1/2 of telisotuzumab adizutecan.

  17. AUC of Telisotuzumab Adizutecan

    Timeframe: Up to 2 Years

    AUC of telisotuzumab adizutecan.

  18. Telisotuzumab Adizutecan ADA

    Timeframe: Up to 2 Years

    Incidence and concentration of telisotuzumab adizutecan ADA.

  19. Telisotuzumab Adizutecan nADA

    Timeframe: Up to 2 Years

    Incidence and concentration of telisotuzumab adizutecan nADA.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • City of Hope National Medical Center /ID# 276272Duarte, United StatesRecruiting
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589Irvine, United StatesRecruiting
  • USC Norris Comprehensive Cancer Center /ID# 279603Los Angeles, United StatesRecruiting
  • University of Illinois Hospital and Health Sciences System /ID# 251750Chicago, United StatesRecruiting
  • University of Chicago Medical Center /ID# 276271Chicago, United StatesRecruiting
  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593Fort Wayne, United StatesRecruiting
  • Community Health Network, Inc. /ID# 243011Indianapolis, United StatesRecruiting
  • Norton Cancer Institute /ID# 248903Louisville, United StatesRecruiting
  • START Midwest /ID# 248685Grand Rapids, United StatesRecruiting
  • M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200Minneapolis, United StatesRecruiting
  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399Omaha, United StatesRecruiting
  • Duke Cancer Institute /ID# 276267Durham, United StatesRecruiting
  • Carolina BioOncology Institute /ID# 232597Huntersville, United StatesRecruiting
  • NEXT Oncology Austin /ID# 243005Austin, United StatesRecruiting
  • The University of Texas MD Anderson Cancer Center /ID# 270059Houston, United StatesRecruiting
  • Next Oncology Dallas /ID# 276254Irving, United StatesRecruiting
  • NEXT Oncology /ID# 243007San Antonio, United StatesRecruiting
  • South Texas Accelerated Research Therapeutics (START) /ID# 276268San Antonio, United StatesRecruiting
  • Start Mountain Region /ID# 276270West Valley City, United StatesRecruiting
  • Virginia Cancer Specialists - Fairfax /ID# 232592Fairfax, United StatesRecruiting
  • Tom Baker Cancer Centre /ID# 276206Calgary, CanadaRecruiting
  • Princess Margaret Cancer Centre /ID# 276275Toronto, CanadaRecruiting
  • Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274Montreal, CanadaRecruiting
  • Shamir Medical Center /ID# 276238Beer Ya'akov, IsraelRecruiting
  • Meir Medical Center /ID# 277327Kefar Sava, IsraelRecruiting

And 23 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (7)

Targets (2)