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RECRUITING

NCT05005403

PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

694

Start Date

2021-11-01

Completion Date

2027-07

Last Updated

2026-04-03

Healthy Volunteers

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 Pancreatic Cancer Triple Negative Breast Cancer

Interventions

DRUG

Azirkitug

Intravenous (IV) Infusion

DRUG

Budigalimab

Intravenous (IV) Infusion

DRUG

Bevacizumab

Intravenous (IV) Infusion

DRUG

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (44)