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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 · AbbVie
In plain English
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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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 694 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-11-01
Estimated completion: 2027-07
Last updated: 2026-04-13
Interventions
Drug: AzirkitugDrug: BudigalimabDrug: BevacizumabDrug: Telisotuzumab Adizutecan
Primary outcomes
- • Number of Participants with Adverse Events (AE) (Up to 2 Years)
- • Maximum Observed Serum Concentration (Cmax) of Azirkitug (Up to 2 Years)
- • Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug (Up to 2 Years)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (44)
City of Hope National Medical Center /ID# 276272Recruiting
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589Recruiting
Irvine, California, United States
University of Illinois Hospital and Health Sciences System /ID# 251750Recruiting
Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593Recruiting
Fort Wayne, Indiana, United States
Community Health Network, Inc. /ID# 243011Recruiting
Indianapolis, Indiana, United States
Norton Cancer Institute /ID# 248903Recruiting
Louisville, Kentucky, United States
START Midwest /ID# 248685Recruiting
Grand Rapids, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200Recruiting
Minneapolis, Minnesota, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399Recruiting
Omaha, Nebraska, United States
Duke Cancer Institute /ID# 276267Recruiting
Durham, North Carolina, United States
Carolina BioOncology Institute /ID# 232597Recruiting
Huntersville, North Carolina, United States
NEXT Oncology Austin /ID# 243005Recruiting
Austin, Texas, United States
The University of Texas MD Anderson Cancer Center /ID# 270059Recruiting
Houston, Texas, United States
Next Oncology - Irving /ID# 276254Recruiting
Irving, Texas, United States
NEXT Oncology /ID# 243007Recruiting
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START) /ID# 276268Recruiting
San Antonio, Texas, United States
Start Mountain Region /ID# 276270Recruiting
West Valley City, Utah, United States
Virginia Cancer Specialists - Fairfax /ID# 232592Recruiting
Fairfax, Virginia, United States
Tom Baker Cancer Centre /ID# 276206Recruiting
Calgary, Alberta, Canada
Shamir Medical Center /ID# 276238Recruiting
Beer Ya'akov, Central District, Israel
Meir Medical Center /ID# 277327Recruiting
Kfar Saba, Central District, Israel
The Chaim Sheba Medical Center /ID# 238332Recruiting
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 276591Recruiting
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 238333Recruiting
Haifa, Israel
Shaare Zedek Medical Center /ID# 276244Recruiting
Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 252287Recruiting
Jerusalem, Israel
Rabin Medical Center. /ID# 250497Recruiting
Petah Tikva, Israel
Aichi Cancer Center Hospital /ID# 250405Recruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 238840Recruiting
Kashiwa-shi, Chiba, Japan
Kobe University Hospital /ID# 250409Recruiting
Kobe, Hyōgo, Japan
Kansai Medical University Hospital /ID# 276805Recruiting
Hirakata-shi, Osaka, Japan
Shizuoka Cancer Center /ID# 250408Recruiting
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 238372Recruiting
Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 276806Recruiting
Wakayama, Wakayama, Japan
National Cancer Center /ID# 252290Recruiting
Goyang-si, Gyeonggido, South Korea
CHA Bundang Medical Center /ID# 252291Recruiting
Seongnam, Gyeonggido, South Korea
Yonsei University Health System Severance Hospital /ID# 252288Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 252289Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
National Taiwan University Hospital /ID# 251894Recruiting
Taipei City, Taipei, Taiwan
Taipei Medical University Shuang Ho Hospital /ID# 252449Recruiting
New Taipei City, Taiwan
National Cheng Kung University Hospital /ID# 252262Recruiting
Tainan, Taiwan
Taipei Medical University Hospital /ID# 252450Recruiting
Taipei, Taiwan
Tri-Service General Hospital /ID# 252263Recruiting
Taipei, Taiwan