What this study is
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.
What's being tested
- Azirkitug
Intervention · DRUG
- Budigalimab
Intervention · DRUG
- Bevacizumab
Intervention · DRUG
- Telisotuzumab Adizutecan
Intervention · DRUG
All interventions
Intravenous (IV) Infusion
Study details
- 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
- Sponsor
- AbbVie
- Conditions
- 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
- Enrolling
- 694 people
- Starts
- 2021-11-01
- Est. completion
- 2027-07
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (45)
44 openCity of Hope National Medical Center /ID# 276272
Duarte, California, United States
RecruitingCity of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
Irvine, California, United States
RecruitingUniversity of Illinois Hospital and Health Sciences System /ID# 251750
Chicago, Illinois, United States
RecruitingFort Wayne Medical Oncology and Hematology, Inc /ID# 232593
Fort Wayne, Indiana, United States
RecruitingCommunity Health Network, Inc. /ID# 243011
Indianapolis, Indiana, United States
RecruitingNorton Cancer Institute /ID# 248903
Louisville, Kentucky, United States
RecruitingSTART Midwest /ID# 248685
Grand Rapids, Michigan, United States
RecruitingM Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200
Minneapolis, Minnesota, United States
RecruitingNebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
Omaha, Nebraska, United States
RecruitingDuke Cancer Institute /ID# 276267
Durham, North Carolina, United States
RecruitingCarolina BioOncology Institute /ID# 232597
Huntersville, North Carolina, United States
- Site Coordinator · Contact844-663-3742
RecruitingNEXT Oncology Austin /ID# 243005
Austin, Texas, United States
RecruitingThe University of Texas MD Anderson Cancer Center /ID# 270059
Houston, Texas, United States
RecruitingNext Oncology - Irving /ID# 276254
Irving, Texas, United States
RecruitingNEXT Oncology /ID# 243007
San Antonio, Texas, United States
RecruitingSouth Texas Accelerated Research Therapeutics (START) /ID# 276268
San Antonio, Texas, United States
RecruitingStart Mountain Region /ID# 276270
West Valley City, Utah, United States
RecruitingVirginia Cancer Specialists - Fairfax /ID# 232592
Fairfax, Virginia, United States
Recruiting
27 sites outside the US
Tom Baker Cancer Centre /ID# 276206
Calgary, Alberta, Canada
RecruitingPrincess Margaret Cancer Centre /ID# 276275
Toronto, Ontario, Canada
RecruitingShamir Medical Center /ID# 276238
Beer Ya'akov, Central District, Israel
RecruitingMeir Medical Center /ID# 277327
Kfar Saba, Central District, Israel
RecruitingThe Chaim Sheba Medical Center /ID# 238332
Ramat Gan, Tel Aviv, Israel
RecruitingTel Aviv Sourasky Medical Center /ID# 276591
Tel Aviv, Tel Aviv, Israel
RecruitingRambam Health Care Campus /ID# 238333
Haifa, Israel
RecruitingShaare Zedek Medical Center /ID# 276244
Jerusalem, Israel
RecruitingHadassah Medical Center-Hebrew University /ID# 252287
Jerusalem, Israel
RecruitingRabin Medical Center. /ID# 250497
Petah Tikva, Israel
RecruitingAichi Cancer Center Hospital /ID# 250405
Nagoya, Aichi-ken, Japan
RecruitingNational Cancer Center Hospital East /ID# 238840
Kashiwa-shi, Chiba, Japan
RecruitingKobe University Hospital /ID# 250409
Kobe, Hyōgo, Japan
RecruitingKansai Medical University Hospital /ID# 276805
Hirakata-shi, Osaka, Japan
RecruitingShizuoka Cancer Center /ID# 250408
Sunto-gun, Shizuoka, Japan
RecruitingNational Cancer Center Hospital /ID# 238372
Chuo-ku, Tokyo, Japan
RecruitingNational Cancer Center /ID# 252290
Goyang-si, Gyeonggido, South Korea
RecruitingCHA Bundang Medical Center /ID# 252291
Seongnam, Gyeonggido, South Korea
RecruitingYonsei University Health System Severance Hospital /ID# 252288
Seoul, Seoul Teugbyeolsi, South Korea
RecruitingAsan Medical Center /ID# 252289
Seoul, Seoul Teugbyeolsi, South Korea
RecruitingThe Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867
Seoul, Seoul Teugbyeolsi, South Korea
RecruitingNational Taiwan University Hospital /ID# 251894
Taipei City, Taipei, Taiwan
RecruitingTaipei Medical University Shuang Ho Hospital /ID# 252449
New Taipei City, Taiwan
RecruitingNational Cheng Kung University Hospital /ID# 252262
Tainan, Taiwan
RecruitingTaipei Medical University Hospital /ID# 252450
Taipei, Taiwan
RecruitingTri-Service General Hospital /ID# 252263
Taipei, Taiwan
RecruitingWakayama Medical University Hospital /ID# 276806
Wakayama, Wakayama, Japan
Completed
Study team
Sponsor
AbbVie
Study ID M21-410
Study director
ABBVIE INC.
AbbVie
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.