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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Azirkitug

Intravenous (IV) Infusion

DRUG

Budigalimab

Intravenous (IV) Infusion

DRUG

Bevacizumab

Intravenous (IV) Infusion

DRUG

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Locations (20)

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