OncoMatch/Clinical Trials/NCT05005403
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
Is NCT05005403 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Azirkitug and Budigalimab for non-small cell lung cancer.
Treatment: Azirkitug · Budigalimab · Bevacizumab · Telisotuzumab Adizutecan — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Gastric Cancer
Esophageal Carcinoma
Ovarian Cancer
Pancreatic Cancer
Triple-Negative Breast Cancer
Breast Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — NSCLC, advanced or metastatic
NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination).
Must have received: anti-PD-1 therapy — NSCLC, advanced or metastatic
NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination).
Must have received: anti-PD-L1 therapy — NSCLC, advanced or metastatic
NSCLC - Advanced or metastatic progressed on standard of care (SOC) including chemotherapy and prior anti-PD-(L)1 antibody (separately or in combination).
Must have received: platinum-based chemotherapy — HNSCC, recurrent or metastatic
HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting.
Must have received: anti-PD-1 therapy — HNSCC, recurrent or metastatic
HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting.
Must have received: anti-PD-L1 therapy — HNSCC, recurrent or metastatic
HSNCC - Advanced/metastatic progressed on platinum and PD-1/PD-LI in recurrent or metastatic setting.
Must have received: oxaliplatin — MSS-CRC
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
Must have received: irinotecan — MSS-CRC
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
Must have received: fluoropyrimidine — MSS-CRC
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
Must have received: anti-EGFR therapy — MSS-CRC
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
Must have received: VEGF inhibitor — MSS-CRC
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
Must have received: VEGFR inhibitor — MSS-CRC
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
Must have received: BRAF inhibitor — MSS-CRC
MSS-CRC - Progressed on ...BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy...
Must have received: HER2-targeted therapy — MSS-CRC
MSS-CRC - Progressed on ...BRAFV600E or HER2, other targetable mutations targeted with locally approved therapy...
Must have received: TAS-102 — MSS-CRC
MSS-CRC - Progressed on ...TAS-102, Regorafenib and not MSI-h or MMR-deficient
Must have received: regorafenib — MSS-CRC
MSS-CRC - Progressed on ...TAS-102, Regorafenib and not MSI-h or MMR-deficient
Must have received: cytotoxic chemotherapy — Gastric/GEJ adenocarcinoma, advanced/metastatic
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
Must have received: immune checkpoint inhibitor — Gastric/GEJ adenocarcinoma, advanced/metastatic
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
Must have received: HER2-targeted therapy — Gastric/GEJ adenocarcinoma, advanced/metastatic
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
Must have received: systemic therapy — HGSOC, post SOC
High-Grade Serous Ovarian Cancer (HGSOC) - Progressed serous epithelial ovarian, fallopian tube or primary peritoneal cancer post SOC and not eligible for surgical resection.
Must have received: platinum-based chemotherapy — HGSOC, platinum resistant
High-Grade Serous Ovarian Cancer (HGSOC) - Platinum resistant cannot have >5 lines of prior therapy.
Must have received: systemic therapy — PDAC, advanced/metastatic
Pancreatic Adenocarcinoma (PDAC) - Advanced/metastatic progressed after SOC. Includes adenosquamous carcinoma and post-Whipple.
Must have received: taxane — TNBC
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope National Medical Center /ID# 276272 · Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 278589 · Irvine, California
- USC Norris Comprehensive Cancer Center /ID# 279603 · Los Angeles, California
- University of Illinois Hospital and Health Sciences System /ID# 251750 · Chicago, Illinois
- University of Chicago Medical Center /ID# 276271 · Chicago, Illinois
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05005403 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemotherapy and anti-PD-1 therapy.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify