Assessing the safety and effects of Azirkitug in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope National Medical Center /ID# 276272
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589
  Irvine, California, United States Recruiting
• USC Norris Comprehensive Cancer Center /ID# 279603
  Los Angeles, California, United States Recruiting
• University of Illinois Hospital and Health Sciences System /ID# 251750
  Chicago, Illinois, United States Recruiting
• University of Chicago Medical Center /ID# 276271
  Chicago, Illinois, United States Recruiting
• Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
  Fort Wayne, Indiana, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.