What is clinical trial NCT05005403 studying?

NCT05005403 is a Phase 1 clinical trial evaluating Azirkitug for Non-Small Cell Lung Cancer. The trial is sponsored by AbbVie and is currently recruiting.

What phase is the NCT05005403 clinical trial?

NCT05005403 is a Phase 1 clinical trial. Phase 3 trials are pivotal studies required before FDA approval, typically enrolling hundreds to thousands of participants to prove efficacy and safety.

Is NCT05005403 still recruiting participants?

The current enrollment status of NCT05005403 is: RECRUITING. The trial is actively enrolling — check ClinicalTrials.gov for eligibility criteria.

Who is the sponsor of clinical trial NCT05005403?

NCT05005403 is sponsored by AbbVie (ABBV). BiotechSign currently grades the sponsor a C (58/100) based on its composite pipeline strength and catalyst outlook.

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NCT05005403Phase 1RECRUITING

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

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

Interventions / Drugs

Azirkitug Budigalimab Bevacizumab Telisotuzumab Adizutecan

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment694 participants

Primary Completion—

Lead SponsorAbbVie

Data Retrieved2026-04-11 02:51:51.325364+00:00

What This Trial Means for Biotech Investors

Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 694 participants

Sponsor Catalyst Profile

AbbVie Inc (ABBV) is the sponsoring company for this trial. BiotechSign currently grades this company C (58/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

ABBV Full Pipeline →All Companies →

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