Recruiting
Phase 1

ABBV-514 & Budigalimab

Sponsor:

AbbVie

Code:

NCT05005403

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Azirkitug

Budigalimab

Bevacizumab

Telisotuzumab Adizutecan

Study Details

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 as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan.

Bevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan 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 will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide.

Participants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan 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.

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

Study ID

NCT05005403

Start date

Nov 1, 2021

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pre Treatment biopsy or archive tissue within 6 months without intervening treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 0 or 1 and a life expectancy of >= 3 months.
  • 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, BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy, 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 or 2 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

Study Design

Enrollment

694 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Escalation: Azirkitug

Participants will receive Azirkitug.

experimental: Part 1 Dose Escalation: Azirkitug + Budigalimab

Participants will receive Azirkitug in combination with budigalimab.

experimental: Part 2 Dose Expansion: Azirkitug

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.

experimental: Part 2 Dose Expansion: Azirkitug + Budigalimab

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.

experimental: Part 3 Dose Expansion: Azirkitug + Budigalimab

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.

experimental: Part 4 Dose Expansion: Azirkitug

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.

experimental: Part 4 Dose Expansion: Azirkitug + Budigalimab

Participants will receive Azirkitug in combination with budigalimab.

experimental: Part 4 Dose Optimization and Randomization: Azirkitug

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion.

experimental: Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab

Participants will receive Azirkitug in combination with budigalimab.

experimental: Part 5 Dose Expansion: Azirkitug + Budigalimab

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.

experimental: Part 6 Dose Expansion: Azirkitug + Budigalimab

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.

experimental: Part 7 Dose Expansion: Azirkitug + Budigalimab

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.

experimental: Part 8 Safety Lead In: Azirkitug + Bevacizumab

Participants will receive Azirkitug in combination with bevacizumab.

experimental: Part 8 Dose Expansion: Azirkitug + Bevacizumab

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab.

experimental: Part 9 Dose Expansion: Azirkitug + Budigalimab

Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab.

experimental: Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan

Participants will receive Azirkitug in combination with telisotuzumab adizutecan.

experimental: Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan

Participants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan.

Interventions

Azirkitug

Intravenous (IV) Infusion

Budigalimab

Intravenous (IV) Infusion

Bevacizumab

Intravenous (IV) Infusion

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AE) [ Time Frame: Up to 2 Years ]
  • Maximum Observed Serum Concentration (Cmax) of Azirkitug [ Time Frame: Up to 2 Years ]
  • Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug [ Time Frame: Up to 2 Years ]
  • Terminal Elimination Half-Life (t1/2) of Azirkitug [ Time Frame: Up to 2 Years ]
  • Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug [ Time Frame: Up to 2 Years ]
  • Azirkitug Antidrug Antibody (ADA) [ Time Frame: Up to 2 Years ]
  • Azirkitug Neutralizing Antidrug Antibody (nADA) [ Time Frame: Up to 2 Years ]
  • Cmax of Budigalimab [ Time Frame: Up to 2 Years ]
  • Tmax of Budigalimab [ Time Frame: Up to 2 Years ]
  • t1/2 of Budigalimab [ Time Frame: Up to 2 Years ]
  • AUC of Budigalimab [ Time Frame: Up to 2 Years ]
  • Budigalimab ADA [ Time Frame: Up to 2 Years ]
  • Budigalimab nADA [ Time Frame: Up to 2 Years ]
  • Cmax of Telisotuzumab Adizutecan [ Time Frame: Up to 2 Years ]
  • Tmax of Telisotuzumab Adizutecan [ Time Frame: Up to 2 Years ]
  • t1/2 of Telisotuzumab Adizutecan [ Time Frame: Up to 2 Years ]
  • AUC of Telisotuzumab Adizutecan [ Time Frame: Up to 2 Years ]
  • Telisotuzumab Adizutecan ADA [ Time Frame: Up to 2 Years ]
  • Telisotuzumab Adizutecan nADA [ Time Frame: Up to 2 Years ]

Central Contacts and Locations

Central contacts

Locations

City of Hope National Medical Center /ID# 276272

Recruiting

Duarte, California, United States, 91010

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589

Recruiting

Irvine, California, United States, 92618

USC Norris Comprehensive Cancer Center /ID# 279603

Recruiting

Los Angeles, California, United States, 90033

University of Illinois Hospital and Health Sciences System /ID# 251750

Recruiting

Chicago, Illinois, United States, 60607

University of Chicago Medical Center /ID# 276271

Recruiting

Chicago, Illinois, United States, 60637

Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593

Recruiting

Fort Wayne, Indiana, United States, 46804

Community Health Network, Inc. /ID# 243011

Recruiting

Indianapolis, Indiana, United States, 46250-2042

Norton Cancer Institute /ID# 248903

Recruiting

Louisville, Kentucky, United States, 40241-2832

START Midwest /ID# 248685

Recruiting

Grand Rapids, Michigan, United States, 49546-7062

M Health Fairview University of Minnesota Medical Center - East Bank /ID# 276200

Recruiting

Minneapolis, Minnesota, United States, 55455

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399

Recruiting

Omaha, Nebraska, United States, 68130

Duke Cancer Institute /ID# 276267

Recruiting

Durham, North Carolina, United States, 27710

Carolina BioOncology Institute /ID# 232597

Recruiting

Huntersville, North Carolina, United States, 28078

Contacts

Site Coordinator

844-663-3742

NEXT Oncology Austin /ID# 243005

Recruiting

Austin, Texas, United States, 78705-1171

The University of Texas MD Anderson Cancer Center /ID# 270059

Recruiting

Houston, Texas, United States, 77030

Next Oncology Dallas /ID# 276254

Recruiting

Irving, Texas, United States, 75039

NEXT Oncology /ID# 243007

Recruiting

San Antonio, Texas, United States, 78229

South Texas Accelerated Research Therapeutics (START) /ID# 276268

Recruiting

San Antonio, Texas, United States, 78229

Start Mountain Region /ID# 276270

Recruiting

West Valley City, Utah, United States, 84119

Virginia Cancer Specialists - Fairfax /ID# 232592

Recruiting

Fairfax, Virginia, United States, 22031

Tom Baker Cancer Centre /ID# 276206

Recruiting

Calgary, Alberta, Canada, T2N 4N2

Princess Margaret Cancer Centre /ID# 276275

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 276274

Recruiting

Montreal, Quebec, Canada, H2X 0C1

More Information

Sponsor

AbbVie

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

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
  • Telisotuzumab Adizutecan
  • ABBV-400

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-06-23.