study to assess adverse events and pharmacokinetics in adult participants with non-small cell lung cancer (nsclc), head and neck squamous cell carcinoma (hnscc) and other solid tumors, receiving intravenous (iv) infusion of azirkitug (abbv-514) alone or in combination with budigalimab or bevacizumab

Conditions: Non-Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Micro Satellite Stable Colorectal Cancer; Gastric/Esophageal Cancer; High-Grade Serous Ovarian Cancer; Pancreatic Cancer; Triple Negative Breast Cancer

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 (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.


Eligibility criteria:
inclusion criteria: * 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 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

Keywords: non-small cell lung cancer nsclc head and neck squamous cell carcinoma hnscc solid tumors budigalimab abbv-181 abbv-514 micro satellite stable colorectal cancer mss-crc, gastric cancer esophageal cancer gea gej high-grade serous ovarian cancer hgsoc pancreatic cancer, pdac triple negative breast cancer tnbc