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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer, sponsored by AbbVie.
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 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT05005403 shows while recruiting
NCT05005403 is an interventional study that assigns participants to a tested intervention. The registered 512 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (21% lower).
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 names 20 study sites across 14 states, led by 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, Microsatellite Stable Colorectal 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.
Learn More About Clinical Trials
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Where NCT05005403's enrollment target sits among peer trials
512 73rd of 454 higher than 382 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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