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
← catalyst calendarNCT05005403 · readout ≤ 346 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
694estimated
Sites
48
Countries
Canada, Israel, Japan +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-11-01 | actual | When the study began enrolling |
| Primary completion | Jul 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-08-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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
- Drug: Azirkitug
- Drug: Budigalimab
- Drug: Bevacizumab
- Drug: Telisotuzumab Adizutecan
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AE)
measured Up to 2 Years
Maximum Observed Serum Concentration (Cmax) of Azirkitug
measured Up to 2 Years
Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug
measured Up to 2 Years
Terminal Elimination Half-Life (t1/2) of Azirkitug
measured Up to 2 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug
measured Up to 2 Years
Azirkitug Antidrug Antibody (ADA)
measured Up to 2 Years
Azirkitug Neutralizing Antidrug Antibody (nADA)
measured Up to 2 Years
Cmax of Budigalimab
measured Up to 2 Years
Tmax of Budigalimab
measured Up to 2 Years
t1/2 of Budigalimab
measured Up to 2 Years
AUC of Budigalimab
measured Up to 2 Years
Budigalimab ADA
measured Up to 2 Years
Budigalimab nADA
measured Up to 2 Years
Cmax of Telisotuzumab Adizutecan
measured Up to 2 Years
Tmax of Telisotuzumab Adizutecan
measured Up to 2 Years
t1/2 of Telisotuzumab Adizutecan
measured Up to 2 Years
AUC of Telisotuzumab Adizutecan
measured Up to 2 Years
Telisotuzumab Adizutecan ADA
measured Up to 2 Years
Telisotuzumab Adizutecan nADA
measured Up to 2 Years
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