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NCT05005403 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab
A Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 512
- Enrollment target
- 20
- Study locations
NCT05005403 is a Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 512 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT05005403, a Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 512 participants
- Enrollment target
- 20
- Study locations
Study 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 (ABBV-514) as a monotherapy and in combination with Budigalimab or Bevacizumab,. Bevacizumab is an approved product, while Budigalimab and Azirkitug (ABBV-514) 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 (ABBV-514) will be explored. Each treatment arm receives a different dose of Azirkitug (ABBV-514) in monotherapy and in combination with Budigalimab or Bevacizumab. Approximately 512 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive Azirkitug (ABBV-514) as a monotherapy or in combination with Budigalimab or Bevacizumab 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 Studied
Interventions
- DRUG Bevacizumab
- DRUG Budigalimab
- DRUG Azirkitug
Study Locations (20)
Texas
- NEXT Oncology Austin /ID# 243005 - Austin
- The University of Texas MD Anderson Cancer Center /ID# 270059 - Houston
- NEXT Oncology /ID# 243007 - San Antonio
- South Texas Accelerated Research Therapeutics (START) /ID# 276268 - San Antonio
Other
- Rambam Health Care Campus /ID# 238333 - Haifa
- Hadassah Medical Center-Hebrew University /ID# 252287 - Jerusalem
- Rabin Medical Center /ID# 250497 - Petah Tikva
Indiana
- Fort Wayne Medical Oncology and Hematology, Inc /ID# 232593 - Fort Wayne
- Community Health Network, Inc. /ID# 243011 - Indianapolis
California
- City of Hope National Medical Center /ID# 276272 - Duarte
Illinois
- University of Illinois Hospital and Health Sciences System /ID# 251750 - Chicago
Kentucky
- Norton Cancer Institute /ID# 248903 - Louisville
Michigan
- START Midwest /ID# 248685 - Grand Rapids
Nebraska
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 247399 - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05005403
The ClinicalTrials.gov registry entry for NCT05005403 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (22% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT05005403 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Texas, Other, Indiana.
Frequently Asked Questions
What is clinical trial NCT05005403 about?
NCT05005403 is a clinical study titled "Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab". 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 can...
What is the current status of trial NCT05005403?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 512 participants. The study started on 2021-11-01. Estimated completion is 2027-06.
What conditions does trial NCT05005403 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Pancreatic Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, High-grade Serous Ovarian Cancer.
What interventions are being tested in trial NCT05005403?
The interventions under investigation include: Bevacizumab (DRUG), Budigalimab (DRUG), Azirkitug (DRUG).
Who is sponsoring clinical trial NCT05005403?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05005403 being conducted?
This trial has 20 study locations across California, Illinois, Indiana, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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