> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-assess-adverse-events-and-pharmacokinetics-in-adult-75ac0852-abf8-4cb9-b25e-7ac41ffa0876 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) Participants 694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) Start date 2021-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) Number of sites 48 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Dates **Completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **First posted** 2021-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Registry last updated** 2026-06-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Primary completion date** 2027-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Start date** 2021-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Size and sites **Participants** 694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Planned participants** 694 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Number of sites** 48 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Identifiers **Registry ID** NCT05005403 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **ClinicalTrials.gov ID** NCT05005403 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05005403) ## Related records ### Drugs (4) - [Azirkitug](https://trialight.com/data/asset/azirkitug-4abb572a-80a6-453e-816e-6de029b59181.md) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Budigalimab](https://trialight.com/data/asset/budigalimab-7fd38766-a4e0-4700-9e19-9d25908c4573.md) - [Telisotuzumab adizutecan](https://trialight.com/data/asset/telisotuzumab-adizutecan-73d60959-a437-4a12-a662-43fd6fc3da77.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (7) - [Esophageal cancer](https://trialight.com/data/condition/esophageal-cancer-a3b5271c-e6d4-537b-8dfd-9391c60e2af2.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) ### Targets (2) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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