A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With Azirkitug (ABBV-514) as a Single Agent and in Combination With Budigalimab or Bevacizumab
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 (ABBV-514) as a monotherapy and in combination with Budigalimab or Bevacizumab,. Bevacizumab is an approved product, while Budigalimab and Azirkitug (ABBV-514) 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 (ABBV-514) will be explored. Each treatment arm receives a different dose of Azirkitug (ABBV-514) in monotherapy and in combination with Budigalimab or Bevacizumab. Approximately 512 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive Azirkitug (ABBV-514) as a monotherapy or in combination with Budigalimab or Bevacizumab 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.
• Pre Treatment biopsy or archive tissue within 6 months without intervening treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of \<=1
• 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, 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 systemic therapy that must have included taxane and treatment naïve to immunotherapy targeting T-cell co-stimulation