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 CancerHead and Neck Squamous Cell CarcinomaMicro Satellite Stable Colorectal CancerGastric/Esophageal CancerHigh-Grade Serous Ovarian CancerPancreatic CancerTriple Negative Breast Cancer
- Interventions
- Registration Number
- NCT05005403
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 512
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 3 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 3 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 4 Dose Expansion: Azirkitug (ABBV-514) Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion. Part 4 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 4 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 5 Dose Expansion: Azirkitug (ABBV-514) Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion. Part 5 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 5 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 6 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 6 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 7 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 7 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab Azirkitug Participants will receive Azirkitug (ABBV-514) in combination with bevacizumab. Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab Bevacizumab Participants will receive Azirkitug (ABBV-514) in combination with bevacizumab. Part 8 Dose Expansion: Azirkitug (ABBV-514) + Bevacizumab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with bevacizumab. Part 8 Dose Expansion: Azirkitug (ABBV-514) + Bevacizumab Bevacizumab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with bevacizumab. Part 9 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 9 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 2 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab. Part 1 Dose Escalation: Azirkitug (ABBV-514) Azirkitug Participants will receive Azirkitug (ABBV-514). Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab Azirkitug Participants will receive Azirkitug (ABBV-514) in combination with budigalimab. Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab Budigalimab Participants will receive Azirkitug (ABBV-514) in combination with budigalimab. Part 2 Dose Expansion: Azirkitug (ABBV-514) Azirkitug Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.
- Primary Outcome Measures
Name Time Method Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514 Up to 2 Years Time to maximum Observed Serum Concentration (Tmax) of of ABBV-514.
Antidrug Antibody (ADA) Up to 2 Years Incidence and concentration of anti-drug antibodies.
Number of Participants with Adverse Events (AE) Up to 2 Years An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Terminal Elimination Half-Life (t1/2) of ABBV-514 Up to 2 Years Terminal elimination half-life (t1/2) of ABBV-514.
Neutralizing Antidrug Antibody (nADA) Up to 2 Years Incidence and concentration of neutralizing anti-drug antibodies.
Maximum Observed Serum Concentration (Cmax) of ABBV-514 Up to 2 Years Maximum Observed Serum Concentration (Cmax) of of ABBV-514.
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514 Up to 2 Years Area under the serum concentration versus time curve (AUC) of ABBV-514.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (35)
Wakayama Medical University Hospital /ID# 276806
🇯🇵Wakayama, Wakayama, Japan
City of Hope National Medical Center /ID# 276272
🇺🇸Duarte, California, United States
University of Illinois Hospital and Health Sciences System /ID# 251750
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593
🇺🇸Fort Wayne, Indiana, United States
Community Health Network, Inc. /ID# 243011
🇺🇸Indianapolis, Indiana, United States
Norton Cancer Institute /ID# 248903
🇺🇸Louisville, Kentucky, United States
START Midwest /ID# 248685
🇺🇸Grand Rapids, Michigan, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399
🇺🇸Omaha, Nebraska, United States
Carolina BioOncology Institute /ID# 232597
🇺🇸Huntersville, North Carolina, United States
NEXT Oncology Austin /ID# 243005
🇺🇸Austin, Texas, United States
Scroll for more (25 remaining)Wakayama Medical University Hospital /ID# 276806🇯🇵Wakayama, Wakayama, Japan