Home › Trials › NCT05005403

Assessing the safety and effects of Azirkitug in cancer patients

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

Phase 1 Interventional AbbVie · NCT05005403

This study is testing a new cancer drug called Azirkitug to see how safe it is and how well it works for adults with certain types of lung and head and neck cancers.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment694 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, budigalimab, bevacizumab, telisotuzumab
Locations45 sites (Duarte, California and 44 other locations)
Trial IDNCT05005403 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and pharmacokinetics of Azirkitug (ABBV-514) in adult patients with Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), and other solid tumors. Participants will receive Azirkitug either alone or in combination with Budigalimab or Bevacizumab, with the aim of determining the maximum-tolerated dose. The study involves grouping participants into treatment arms based on the dosage they receive. The focus is on understanding adverse events and how the drug is processed in the body.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic NSCLC, HNSCC, or other specified solid tumors who have progressed on standard treatments.

Not a fit: Patients with early-stage cancer or those who have not yet received standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar investigational approaches, but the specific combination of drugs in this study is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Duarte, California and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Small Cell Lung CancerHead and Neck Squamous Cell CarcinomaMicro Satellite Stable Colorectal CancerGastric/Esophageal CancerHigh-Grade Serous Ovarian CancerPancreatic CancerTriple Negative Breast CancerNSCLC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.