RecruitingPhase 1NCT05005403

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

A Global First-in-Human Study in NSCLC, HNSCC, and Solid Tumors With Azirkitug as a Single Agent and in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan

Sponsor

AbbVie

Enrollment

694 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug in adults with several types of advanced cancer — including non-small cell lung cancer (NSCLC), head and neck cancers, and colorectal cancer — that have stopped responding to standard treatments including chemotherapy and immunotherapy. **You may be eligible if...** - You are 18 or older with advanced or metastatic cancer (lung, head and neck, or colorectal) - Your cancer has progressed after standard treatments including chemotherapy and prior immunotherapy (anti-PD-1/PD-L1) - Your general health is fairly good (ECOG ≤1) - You have measurable disease on imaging scans - You are willing to provide a recent tumor tissue sample **You may NOT be eligible if...** - You have not yet tried standard treatments - Your tumor biopsy or tissue sample is not available - Your general health or organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzirkitug

Intravenous (IV) Infusion

DRUGBudigalimab

Intravenous (IV) Infusion

DRUGBevacizumab

Intravenous (IV) Infusion

DRUGTelisotuzumab Adizutecan

Intravenous (IV) Infusion

Locations(44)

City of Hope National Medical Center /ID# 276272

Duarte, California, United States

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

Irvine, 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

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

Minneapolis, Minnesota, United States

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

Omaha, Nebraska, United States

Duke Cancer Institute /ID# 276267

Durham, North Carolina, United States

Carolina BioOncology Institute /ID# 232597

Huntersville, North Carolina, United States

NEXT Oncology Austin /ID# 243005

Austin, Texas, United States

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

Houston, Texas, United States

Next Oncology - Irving /ID# 276254

Irving, Texas, United States

NEXT Oncology /ID# 243007

San Antonio, Texas, United States

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

San Antonio, Texas, United States

Start Mountain Region /ID# 276270

West Valley City, Utah, United States

Virginia Cancer Specialists - Fairfax /ID# 232592

Fairfax, Virginia, United States

Tom Baker Cancer Centre /ID# 276206

Calgary, Alberta, Canada

Shamir Medical Center /ID# 276238

Beer Ya'akov, Central District, Israel

Meir Medical Center /ID# 277327

Kfar Saba, Central District, Israel

The Chaim Sheba Medical Center /ID# 238332

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 276591

Tel Aviv, Tel Aviv, Israel

Rambam Health Care Campus /ID# 238333

Haifa, Israel

Shaare Zedek Medical Center /ID# 276244

Jerusalem, Israel

Hadassah Medical Center-Hebrew University /ID# 252287

Jerusalem, Israel

Rabin Medical Center. /ID# 250497

Petah Tikva, Israel

Aichi Cancer Center Hospital /ID# 250405

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East /ID# 238840

Kashiwa-shi, Chiba, Japan

Kobe University Hospital /ID# 250409

Kobe, Hyōgo, Japan

Kansai Medical University Hospital /ID# 276805

Hirakata-shi, Osaka, Japan

Shizuoka Cancer Center /ID# 250408

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital /ID# 238372

Chuo-ku, Tokyo, Japan

Wakayama Medical University Hospital /ID# 276806

Wakayama, Wakayama, Japan

National Cancer Center /ID# 252290

Goyang-si, Gyeonggido, South Korea

CHA Bundang Medical Center /ID# 252291

Seongnam, Gyeonggido, South Korea

Yonsei University Health System Severance Hospital /ID# 252288

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center /ID# 252289

Seoul, Seoul Teugbyeolsi, South Korea

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

Seoul, Seoul Teugbyeolsi, South Korea

National Taiwan University Hospital /ID# 251894

Taipei City, Taipei, Taiwan

Taipei Medical University Shuang Ho Hospital /ID# 252449

New Taipei City, Taiwan

National Cheng Kung University Hospital /ID# 252262

Tainan, Taiwan

Taipei Medical University Hospital /ID# 252450

Taipei, Taiwan

Tri-Service General Hospital /ID# 252263

Taipei, Taiwan

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NCT05005403