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

Launched by ABBVIE · Aug 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two investigational drugs, ABBV-514 and Budigalimab, to see how they affect adults with advanced Non-Small Cell Lung Cancer (NSCLC) or Head and Neck Squamous Cell Carcinoma (HNSCC). The goal is to understand the safety of these treatments, how they work in the body, and to find the best dosage. About 268 adult participants will join the study at around 80 sites worldwide, receiving the drugs through an intravenous (IV) infusion for up to two years.

To be eligible, participants should have advanced solid tumors that have not responded to or are not suitable for standard treatments. This includes people with specific types of NSCLC or HNSCC who have already been treated with certain chemotherapy and targeted therapies. Throughout the trial, participants will have regular medical check-ups, including blood tests and assessments for side effects, to monitor how well the treatment is working. It's important to note that this trial may require more visits and monitoring compared to regular treatment, as the researchers aim to gather detailed information about the drugs being tested.

Gender

ALL

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