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NCT05005403PHASE1Recruiting

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

AbbVie

Start Date

11/1/2021

Completion Date

7/1/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Azirkitug

DRUG

Budigalimab

DRUG

Bevacizumab

DRUG

Telisotuzumab Adizutecan

Interested in This Trial?

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Conditions

Non-Small Cell Lung CancerHead and Neck Squamous Cell CarcinomaMicro Satellite Stable Colorectal CancerGastric/Esophageal CancerHigh-Grade Serous Ovarian CancerPancreatic CancerTriple Negative Breast Cancer

Locations

City of Hope National Medical Center /ID# 276272

Duarte, California 91010

United States

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

Irvine, California 92618

United States

USC Norris Comprehensive Cancer Center /ID# 279603

Los Angeles, California 90033

United States

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

Chicago, Illinois 60607

United States

University of Chicago Medical Center /ID# 276271

Chicago, Illinois 60637

United States

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

Fort Wayne, Indiana 46804

United States

Community Health Network, Inc. /ID# 243011

Indianapolis, Indiana 46250-2042

United States

Norton Cancer Institute /ID# 248903

Louisville, Kentucky 40241-2832

United States

START Midwest /ID# 248685

Grand Rapids, Michigan 49546-7062

United States

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

Minneapolis, Minnesota 55455

United States

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

Omaha, Nebraska 68130

United States

Duke Cancer Institute /ID# 276267

Durham, North Carolina 27710

United States

Carolina BioOncology Institute /ID# 232597

Huntersville, North Carolina 28078

United States

NEXT Oncology Austin /ID# 243005

Austin, Texas 78705-1171

United States

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

Houston, Texas 77030

United States

Next Oncology Dallas /ID# 276254

Irving, Texas 75039

United States

NEXT Oncology /ID# 243007

San Antonio, Texas 78229

United States

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

San Antonio, Texas 78229

United States

Start Mountain Region /ID# 276270

West Valley City, Utah 84119

United States

Virginia Cancer Specialists - Fairfax /ID# 232592

Fairfax, Virginia 22031

United States

Tom Baker Cancer Centre /ID# 276206

Calgary, Alberta T2N 4N2

Canada

Princess Margaret Cancer Centre /ID# 276275

Toronto, Ontario M5G 2M9

Canada

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

Montreal, Quebec H2X 0C1

Canada

Shamir Medical Center /ID# 276238

Beer Ya'akov, Central District 70300

Israel

Meir Medical Center /ID# 277327

Kefar Sava, Central District 4428164

Israel

Rabin Medical Center. /ID# 250497

Petah Tikva, Central District 4941492

Israel

The Chaim Sheba Medical Center /ID# 238332

Ramat Gan, Tel Aviv 5265601

Israel

Tel Aviv Sourasky Medical Center /ID# 276591

Tel Aviv, Tel Aviv 6423906

Israel

Rambam Health Care Campus /ID# 238333

Haifa, 3109601

Israel

Shaare Zedek Medical Center /ID# 276244

Jerusalem, 9103102

Israel

Hadassah Medical Center-Hebrew University /ID# 252287

Jerusalem, 91120

Israel

Aichi Cancer Center Hospital /ID# 250405

Nagoya, Aichi-ken 464-8681

Japan

National Cancer Center Hospital East /ID# 238840

Kashiwa-shi, Chiba 277-8577

Japan

Kobe University Hospital /ID# 250409

Kobe, Hyōgo 650-0017

Japan

Kansai Medical University Hospital /ID# 276805

Hirakata-shi, Osaka 573-1191

Japan

Shizuoka Cancer Center /ID# 250408

Sunto-gun, Shizuoka 411-8777

Japan

National Cancer Center Hospital /ID# 238372

Chuo-ku, Tokyo 104-0045

Japan

Wakayama Medical University Hospital /ID# 276806

Wakayama, Wakayama 641-8510

Japan

National Cancer Center /ID# 252290

Goyang-si, Gyeonggido 10408

South Korea

CHA Bundang Medical Center /ID# 252291

Seongnam, Gyeonggido 13496

South Korea

Yonsei University Health System Severance Hospital /ID# 252288

Seoul, Seoul Teugbyeolsi 03722

South Korea

Asan Medical Center /ID# 252289

Seoul, Seoul Teugbyeolsi 05505

South Korea

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

Seoul, Seoul Teugbyeolsi 06591

South Korea

Taipei Medical University Shuang Ho Hospital /ID# 252449

New Taipei City, 23561

Taiwan

National Cheng Kung University Hospital /ID# 252262

Tainan, 704

Taiwan

National Taiwan University Hospital /ID# 251894

Taipei, 100

Taiwan

Taipei Medical University Hospital /ID# 252450

Taipei, 11031

Taiwan

Tri-Service General Hospital /ID# 252263

Taipei, 11490

Taiwan