Tests azirkitug alone or combined in adults with several solid tumors
Tests azirkitug, alone or with other drugs, in adults with solid tumors.
Key facts
- Who runs it
- AbbVie
- Where
- New Taipei City, Tainan, and Taipei, TaiwanSee the 5 sitesAlso in 5 other countries, 43 sites
- Trial code
- Registry 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
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 694 people, planned
- Started
- 1 Nov 2021
- Expected to end
- Jul 2027
- Type of study
- Interventional, 17 groups
- Treatments tested
- Azirkitug
- Budigalimab
- Bevacizumab
- Telisotuzumab Adizutecan
- Record updated
- 23 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced non-small cell lung cancer, head and neck cancer or other solid tumors that got worse after standard treatment.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Advanced or metastatic cancer that got worse after standard treatment. Cancer types: non-small cell lung, head and neck squamous cell, microsatellite stable colorectal, gastric/gastroesophageal junction, high-grade serous ovarian, pancreatic adenocarcinoma, and triple negative breast cancer. Measurable disease is needed.
- Earlier treatment
- Lung cancer: progressed on standard care including chemotherapy and an anti-PD-(L)1 antibody. Head and neck cancer: progressed on platinum and PD-1/PD-L1 treatment. Other cancers need prior standard treatments, as listed in the record. Triple negative breast cancer: no prior immunotherapy targeting T-cell co-stimulation.
- Biomarker or test result
- Colorectal cancer must not be MSI-h or MMR-deficient. Lung cancer with actionable gene changes can join if targeted treatments failed.
Main reasons for not taking part
- Major surgery within 28 days before dosing
- Active autoimmune or immunodeficiency disease, with limited exceptions
- Pregnancy
- Live vaccines, or immunosuppressive medicine with limited exceptions
- Anticancer therapy within 5 half-lives or 28 days (whichever is shorter)
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- No major surgery within 28 days prior to dosing
- 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
- 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
- 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 active autoimmune/immunodeficiency disease with limited exceptions
- Pregnancy
Where in Taiwan
Also in 5 other countries, 43 sites
- Taipei Medical University Shuang Ho Hospital /ID# 252449New Taipei City, TaiwanTaking people
- National Cheng Kung University Hospital /ID# 252262Tainan, TaiwanTaking people
- National Taiwan University Hospital /ID# 251894Taipei, TaiwanTaking people
- Taipei Medical University Hospital /ID# 252450Taipei, TaiwanTaking people
- Tri-Service General Hospital /ID# 252263Taipei, TaiwanTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 17 groups in the trial
- Part 1 Dose Escalation: AzirkitugTreatment being tested
Participants will receive Azirkitug.
Treatment: Azirkitug
- Part 1 Dose Escalation: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 2 Dose Expansion: AzirkitugTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
Treatment: Azirkitug
- Part 2 Dose Expansion: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 3 Dose Expansion: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 4 Dose Expansion: AzirkitugTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
Treatment: Azirkitug
- Part 4 Dose Expansion: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 4 Dose Optimization and Randomization: AzirkitugTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.
Treatment: Azirkitug
- Part 4 Dose Optimization & Randomization Azirkitug+BudigalimabTreatment being tested
Participants will receive Azirkitug in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 5 Dose Expansion: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 6 Dose Expansion: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 7 Dose Expansion: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 8 Safety Lead In: Azirkitug + BevacizumabTreatment being tested
Participants will receive Azirkitug in combination with bevacizumab.
Treatment: Azirkitug and Bevacizumab
- Part 8 Dose Expansion: Azirkitug + BevacizumabTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab.
Treatment: Azirkitug and Bevacizumab
- Part 9 Dose Expansion: Azirkitug + BudigalimabTreatment being tested
Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.
Treatment: Azirkitug and Budigalimab
- Part 10 Safety Lead In: Azirkitug + Telisotuzumab AdizutecanTreatment being tested
Participants will receive Azirkitug in combination with telisotuzumab adizutecan.
Treatment: Azirkitug and Telisotuzumab Adizutecan
- Part 10 Dose Expansion: Azirkitug+Telisotuzumab AdizutecanTreatment being tested
Participants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan.
Treatment: Azirkitug and Telisotuzumab Adizutecan
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests azirkitug alone or combined in adults with several solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 23 June 2026