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

Study Overview

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

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.

N/A

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

DRUG: Azirkitug
DRUG: Budigalimab
DRUG: Bevacizumab

M21-410

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-08-12	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-21
First Submitted that Met QC Criteria 2021-08-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-24
First Posted (ACTUAL) 2021-08-13	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part 1 Dose Escalation: Azirkitug (ABBV-514) Participants will receive Azirkitug (ABBV-514).	DRUG: Azirkitug Intravenous (IV) Infusion DRUG: Budigalimab Intravenous (IV) Infusion
EXPERIMENTAL: Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) in combination with budigalimab.	DRUG: Azirkitug Intravenous (IV) Infusion DRUG: Budigalimab Intravenous (IV) Infusion
EXPERIMENTAL: Part 2 Dose Expansion: Azirkitug (ABBV-514) Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.	DRUG: Azirkitug Intravenous (IV) Infusion DRUG: Budigalimab Intravenous (IV) Infusion
EXPERIMENTAL: Part 2 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.	DRUG: Azirkitug Intravenous (IV) Infusion DRUG: Budigalimab Intravenous (IV) Infusion
EXPERIMENTAL: Part 3 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.	DRUG: Budigalimab Intravenous (IV) Infusion
EXPERIMENTAL: Part 4 Dose Expansion: Azirkitug (ABBV-514) Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.	DRUG: Budigalimab Intravenous (IV) Infusion
EXPERIMENTAL: Part 4 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.	DRUG: Budigalimab Intravenous (IV) Infusion
EXPERIMENTAL: Part 5 Dose Expansion: Azirkitug (ABBV-514) Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.
EXPERIMENTAL: Part 5 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
EXPERIMENTAL: Part 6 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
EXPERIMENTAL: Part 7 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.
EXPERIMENTAL: Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab Participants will receive Azirkitug (ABBV-514) in combination with bevacizumab.	DRUG: Bevacizumab Intravenous (IV) Infusion
EXPERIMENTAL: Part 8 Dose Expansion: Azirkitug (ABBV-514) + Bevacizumab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with bevacizumab.	DRUG: Bevacizumab Intravenous (IV) Infusion
EXPERIMENTAL: Part 9 Dose Expansion: Azirkitug (ABBV-514) + Budigalimab Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion in combination with budigalimab.

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants with Adverse Events (AE)	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.	Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of ABBV-514	Maximum Observed Serum Concentration (Cmax) of of ABBV-514.	Up to 2 Years
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-514	Time to maximum Observed Serum Concentration (Tmax) of of ABBV-514.	Up to 2 Years
Terminal Elimination Half-Life (t1/2) of ABBV-514	Terminal elimination half-life (t1/2) of ABBV-514.	Up to 2 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514	Area under the serum concentration versus time curve (AUC) of ABBV-514.	Up to 2 Years
Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to 2 Years
Neutralizing Antidrug Antibody (nADA)	Incidence and concentration of neutralizing anti-drug antibodies.	Up to 2 Years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ABBVIE CALL CENTER

Phone Number: 844-663-3742

Email: abbvieclinicaltrials@abbvie.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: ABBVIE INC., AbbVie

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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