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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

NCT ID: NCT05005403

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Dose Escalation: Azirkitug (ABBV-514)

Participants will receive Azirkitug (ABBV-514).

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Part 1 Dose Escalation: Azirkitug (ABBV-514) + Budigalimab

Participants will receive Azirkitug (ABBV-514) in combination with budigalimab.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

Part 2 Dose Expansion: Azirkitug (ABBV-514)

Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

Part 4 Dose Expansion: Azirkitug (ABBV-514)

Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

Part 5 Dose Expansion: Azirkitug (ABBV-514)

Participants will receive Azirkitug (ABBV-514) at recommended dose determined in Dose Escalation portion.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

Part 8 Dose Escalation: Azirkitug (ABBV-514) + Bevacizumab

Participants will receive Azirkitug (ABBV-514) in combination with bevacizumab.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Bevacizumab

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Bevacizumab

Intervention Type DRUG

Intravenous (IV) Infusion

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.

Group Type EXPERIMENTAL

Azirkitug

Intervention Type DRUG

Intravenous (IV) Infusion

Budigalimab

Intervention Type DRUG

Intravenous (IV) Infusion

Interventions

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Azirkitug

Intravenous (IV) Infusion

Intervention Type DRUG

Budigalimab

Intravenous (IV) Infusion

Intervention Type DRUG

Bevacizumab

Intravenous (IV) Infusion

Intervention Type DRUG

Other Intervention Names

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ABBV-514 ABBV-181

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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City of Hope National Medical Center /ID# 276272

Duarte, California, United States

Site Status RECRUITING

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

Chicago, Illinois, United States

Site Status RECRUITING

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

Fort Wayne, Indiana, United States

Site Status RECRUITING

Community Health Network, Inc. /ID# 243011

Indianapolis, Indiana, United States

Site Status RECRUITING

Norton Cancer Institute /ID# 248903

Louisville, Kentucky, United States

Site Status RECRUITING

START Midwest /ID# 248685

Grand Rapids, Michigan, United States

Site Status RECRUITING

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

Omaha, Nebraska, United States

Site Status RECRUITING

Carolina BioOncology Institute /ID# 232597

Huntersville, North Carolina, United States

Site Status RECRUITING

NEXT Oncology Austin /ID# 243005

Austin, Texas, United States

Site Status RECRUITING

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

Houston, Texas, United States

Site Status RECRUITING

NEXT Oncology /ID# 243007

San Antonio, Texas, United States

Site Status RECRUITING

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

San Antonio, Texas, United States

Site Status RECRUITING

Start Mountain Region /ID# 276270

West Valley City, Utah, United States

Site Status RECRUITING

Virginia Cancer Specialists - Fairfax /ID# 232592

Fairfax, Virginia, United States

Site Status RECRUITING

The Chaim Sheba Medical Center /ID# 238332

Ramat Gan, Tel Aviv, Israel

Site Status RECRUITING

Rambam Health Care Campus /ID# 238333

Haifa, , Israel

Site Status RECRUITING

Hadassah Medical Center-Hebrew University /ID# 252287

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center /ID# 250497

Petah Tikva, , Israel

Site Status RECRUITING

Aichi Cancer Center Hospital /ID# 250405

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

National Cancer Center Hospital East /ID# 238840

Kashiwa-shi, Chiba, Japan

Site Status RECRUITING

Kobe University Hospital /ID# 250409

Kobe, Hyōgo, Japan

Site Status RECRUITING

Kansai Medical University Hospital /ID# 276805

Hirakata-shi, Osaka, Japan

Site Status RECRUITING

Shizuoka Cancer Center /ID# 250408

Sunto-gun, Shizuoka, Japan

Site Status RECRUITING

National Cancer Center Hospital /ID# 238372

Chuo-ku, Tokyo, Japan

Site Status RECRUITING

Wakayama Medical University Hospital /ID# 276806

Wakayama, Wakayama, Japan

Site Status RECRUITING

National Cancer Center /ID# 252290

Goyang-si, Gyeonggido, South Korea

Site Status RECRUITING

CHA Bundang Medical Center /ID# 252291

Seongnam, Gyeonggido, South Korea

Site Status RECRUITING

Yonsei University Health System Severance Hospital /ID# 252288

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

Asan Medical Center /ID# 252289

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252867

Seoul, Seoul Teugbyeolsi, South Korea

Site Status RECRUITING

National Taiwan University Hospital /ID# 251894

Taipei City, Taipei, Taiwan

Site Status RECRUITING

Taipei Medical University Shuang Ho Hospital /ID# 252449

New Taipei City, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital /ID# 252262

Tainan City, , Taiwan

Site Status RECRUITING

Taipei Medical University Hospital /ID# 252450

Taipei, , Taiwan

Site Status RECRUITING

Tri-Service General Hospital /ID# 252263

Taipei, , Taiwan

Site Status RECRUITING

Countries

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United States Israel Japan South Korea Taiwan

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

[email protected]
844-663-3742

Facility Contacts

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Site Coordinator

Role: primary

844-663-3742

Other Identifiers

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M21-410

Identifier Type: -

Identifier Source: org_study_id

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