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

NCT05005403 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M21-410
• Study Type: interventional
• Target: 694
• Locations: 6 countries
• Sites: 48

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; Gastric/Esophageal Cancer; Micro Satellite Stable Colorectal Cancer; High-Grade Serous Ovarian Cancer; Pancreatic Cancer; Triple Negative Breast Cancer

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

Outcome Measures

Primary Outcomes (19)

• Number of Participants with Adverse Events (AE)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  Up to 2 Years

• Maximum Observed Serum Concentration (Cmax) of Azirkitug

  Maximum Observed Serum Concentration (Cmax) of azirkitug.

  Up to 2 Years

• Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug

  Time to maximum Observed Serum Concentration (Tmax) of azirkitug.

  Up to 2 Years

• Terminal Elimination Half-Life (t1/2) of Azirkitug

  Terminal elimination half-life (t1/2) of azirkitug.

  Up to 2 Years

• Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug

  Area under the serum concentration versus time curve (AUC) of azirkitug.

  Up to 2 Years

• Azirkitug Antidrug Antibody (ADA)

  Incidence and concentration of azirkitug anti-drug antibodies.

  Up to 2 Years

• Azirkitug Neutralizing Antidrug Antibody (nADA)

  Incidence and concentration of azirkitug neutralizing anti-drug antibodies.

  Up to 2 Years

• Cmax of Budigalimab

  Cmax of budigalimab.

  Up to 2 Years

• Tmax of Budigalimab

  Tmax of budigalimab.

  Up to 2 Years

• t1/2 of Budigalimab

  t1/2 of budigalimab.

  Up to 2 Years

• AUC of Budigalimab

  AUC of budigalimab.

  Up to 2 Years

• Budigalimab ADA

  Incidence and concentration of budigalimab ADA.

  Up to 2 Years

• Budigalimab nADA

  Incidence and concentration of budigalimab nADA.

  Up to 2 Years

• Cmax of Telisotuzumab Adizutecan

  Cmax of telisotuzumab adizutecan.

  Up to 2 Years

• Tmax of Telisotuzumab Adizutecan

  Tmax of telisotuzumab adizutecan.

  Up to 2 Years

• t1/2 of Telisotuzumab Adizutecan

  t1/2 of telisotuzumab adizutecan.

  Up to 2 Years

• AUC of Telisotuzumab Adizutecan

  AUC of telisotuzumab adizutecan.

  Up to 2 Years

• Telisotuzumab Adizutecan ADA

  Incidence and concentration of telisotuzumab adizutecan ADA.

  Up to 2 Years

• Telisotuzumab Adizutecan nADA

  Incidence and concentration of telisotuzumab adizutecan nADA.

  Up to 2 Years

Study Arms (17)

Part 1 Dose Escalation: Azirkitug

EXPERIMENTAL

Participants will receive Azirkitug.

Drug: Azirkitug

Part 1 Dose Escalation: Azirkitug + Budigalimab

EXPERIMENTAL

Participants will receive Azirkitug in combination with budigalimab.

Drug: Azirkitug; Drug: Budigalimab

Part 2 Dose Expansion: Azirkitug

EXPERIMENTAL

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

Drug: Azirkitug

Part 2 Dose Expansion: Azirkitug + Budigalimab

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Budigalimab

Part 3 Dose Expansion: Azirkitug + Budigalimab

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Budigalimab

Part 4 Dose Expansion: Azirkitug

EXPERIMENTAL

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

Drug: Azirkitug

Part 4 Dose Expansion: Azirkitug + Budigalimab

EXPERIMENTAL

Participants will receive Azirkitug in combination with budigalimab.

Drug: Azirkitug; Drug: Budigalimab

Part 4 Dose Optimization and Randomization: Azirkitug

EXPERIMENTAL

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

Drug: Azirkitug

Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab

EXPERIMENTAL

Participants will receive Azirkitug in combination with budigalimab.

Drug: Azirkitug; Drug: Budigalimab

Part 5 Dose Expansion: Azirkitug + Budigalimab

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Budigalimab

Part 6 Dose Expansion: Azirkitug + Budigalimab

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Budigalimab

Part 7 Dose Expansion: Azirkitug + Budigalimab

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Budigalimab

Part 8 Safety Lead In: Azirkitug + Bevacizumab

EXPERIMENTAL

Participants will receive Azirkitug in combination with bevacizumab.

Drug: Azirkitug; Drug: Bevacizumab

Part 8 Dose Expansion: Azirkitug + Bevacizumab

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Bevacizumab

Part 9 Dose Expansion: Azirkitug + Budigalimab

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Budigalimab

Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan

EXPERIMENTAL

Participants will receive Azirkitug in combination with telisotuzumab adizutecan.

Drug: Azirkitug; Drug: Telisotuzumab Adizutecan

Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan

EXPERIMENTAL

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

Drug: Azirkitug; Drug: Telisotuzumab Adizutecan

Interventions

Bevacizumab DRUG

Intravenous (IV) Infusion

Part 8 Dose Expansion: Azirkitug + Bevacizumab; Part 8 Safety Lead In: Azirkitug + Bevacizumab

Azirkitug DRUG

Intravenous (IV) Infusion

Part 1 Dose Escalation: Azirkitug; Part 1 Dose Escalation: Azirkitug + Budigalimab; Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan; Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan; Part 2 Dose Expansion: Azirkitug; Part 2 Dose Expansion: Azirkitug + Budigalimab; Part 3 Dose Expansion: Azirkitug + Budigalimab; Part 4 Dose Expansion: Azirkitug; Part 4 Dose Expansion: Azirkitug + Budigalimab; Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab; Part 4 Dose Optimization and Randomization: Azirkitug; Part 5 Dose Expansion: Azirkitug + Budigalimab; Part 6 Dose Expansion: Azirkitug + Budigalimab; Part 7 Dose Expansion: Azirkitug + Budigalimab; Part 8 Dose Expansion: Azirkitug + Bevacizumab; Part 8 Safety Lead In: Azirkitug + Bevacizumab; Part 9 Dose Expansion: Azirkitug + Budigalimab

Budigalimab DRUG

Intravenous (IV) Infusion

Part 1 Dose Escalation: Azirkitug + Budigalimab; Part 2 Dose Expansion: Azirkitug + Budigalimab; Part 3 Dose Expansion: Azirkitug + Budigalimab; Part 4 Dose Expansion: Azirkitug + Budigalimab; Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab; Part 5 Dose Expansion: Azirkitug + Budigalimab; Part 6 Dose Expansion: Azirkitug + Budigalimab; Part 7 Dose Expansion: Azirkitug + Budigalimab; Part 9 Dose Expansion: Azirkitug + Budigalimab

Telisotuzumab Adizutecan DRUG

Intravenous (IV) Infusion

Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan; Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (48)

City of Hope National Medical Center /ID# 276272

Duarte, California, 91010, United States

RECRUITING

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

Irvine, California, 92618, United States

RECRUITING

USC Norris Comprehensive Cancer Center /ID# 279603

Los Angeles, California, 90033, United States

RECRUITING

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

Chicago, Illinois, 60607, United States

RECRUITING

University of Chicago Medical Center /ID# 276271

Chicago, Illinois, 60637, United States

RECRUITING

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

Fort Wayne, Indiana, 46804, United States

RECRUITING

Community Health Network, Inc. /ID# 243011

Indianapolis, Indiana, 46250-2042, United States

RECRUITING

Norton Cancer Institute /ID# 248903

Louisville, Kentucky, 40241-2832, United States

RECRUITING

START Midwest /ID# 248685

Grand Rapids, Michigan, 49546-7062, United States

RECRUITING

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

Minneapolis, Minnesota, 55455, United States

RECRUITING

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

Omaha, Nebraska, 68130, United States

RECRUITING

Duke Cancer Institute /ID# 276267

Durham, North Carolina, 27710, United States

RECRUITING

Carolina BioOncology Institute /ID# 232597

Huntersville, North Carolina, 28078, United States

RECRUITING

NEXT Oncology Austin /ID# 243005

Austin, Texas, 78705-1171, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

Next Oncology Dallas /ID# 276254

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology /ID# 243007

San Antonio, Texas, 78229, United States

RECRUITING

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

San Antonio, Texas, 78229, United States

RECRUITING

Start Mountain Region /ID# 276270

West Valley City, Utah, 84119, United States

RECRUITING

Virginia Cancer Specialists - Fairfax /ID# 232592

Fairfax, Virginia, 22031, United States

RECRUITING

Tom Baker Cancer Centre /ID# 276206

Calgary, Alberta, T2N 4N2, Canada

RECRUITING

Princess Margaret Cancer Centre /ID# 276275

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Shamir Medical Center /ID# 276238

Beer Ya'akov, Central District, 70300, Israel

RECRUITING

Meir Medical Center /ID# 277327

Kefar Sava, Central District, 4428164, Israel

RECRUITING

Rabin Medical Center. /ID# 250497

Petah Tikva, Central District, 4941492, Israel

RECRUITING

The Chaim Sheba Medical Center /ID# 238332

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 276591

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

Rambam Health Care Campus /ID# 238333

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center /ID# 276244

Jerusalem, 9103102, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 252287

Jerusalem, 91120, Israel

RECRUITING

Aichi Cancer Center Hospital /ID# 250405

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East /ID# 238840

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

Kobe University Hospital /ID# 250409

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Kansai Medical University Hospital /ID# 276805

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Shizuoka Cancer Center /ID# 250408

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital /ID# 238372

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

Wakayama Medical University Hospital /ID# 276806

Wakayama, Wakayama, 641-8510, Japan

COMPLETED

National Cancer Center /ID# 252290

Goyang-si, Gyeonggido, 10408, South Korea

RECRUITING

CHA Bundang Medical Center /ID# 252291

Seongnam, Gyeonggido, 13496, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 252288

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Asan Medical Center /ID# 252289

Seoul, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

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

Seoul, Seoul Teugbyeolsi, 06591, South Korea

RECRUITING

Taipei Medical University Shuang Ho Hospital /ID# 252449

New Taipei City, 23561, Taiwan

RECRUITING

National Cheng Kung University Hospital /ID# 252262

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital /ID# 251894

Taipei, 100, Taiwan

RECRUITING

Taipei Medical University Hospital /ID# 252450

Taipei, 11031, Taiwan

RECRUITING

Tri-Service General Hospital /ID# 252263

Taipei, 11490, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Esophageal Neoplasms; Pancreatic Neoplasms; Triple Negative Breast Neoplasms; Stomach Neoplasms; Anophthalmia with pulmonary hypoplasia

Interventions

budigalimab; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 13, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7); KR (5); TW (5); IL (8); US (20); CA (3)