A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
42actual
Sites
7
Country
United States
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 | 2022-12-13 | actual | When the study began enrolling |
| Primary completion | 2025-09-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-22 | actual | The whole study's end, after follow-up |
| First posted | 2022-03-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Head and Neck Cancer
- Squamous Cell Carcinoma of Head and Neck
- Recurrent Squamous Cell Carcinoma of the Head and Neck
- Metastatic Cancer
- Metastatic Squamous Cell Carcinoma of the Head and Neck
Interventions
- Biological: Ozuriftamab Vedotin
- Biological: Pembrolizumab
- Biological: Evalstotug (BA3071)
- Biological: Cetuximab — also filed as Erbitux
Primary outcomes
what the primary-completion date above is the date OFConfirmed Objective Response Rate (ORR) per RECIST v1.1
measured Up to 24 months
Incidence of Adverse Events or Serious Adverse Events as assessed by CTCAE v5
measured Up to 24 months
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