A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT05271604 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-09-26
Summary
This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
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
Conditionally active biologic anti-ROR2 antibody drug conjugate
- BIOLOGICAL
-
PD-1 inhibitor
- BIOLOGICAL
-
Evalstotug (BA3071)
Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
- BIOLOGICAL
-
Epidermal growth factor receptor (EGFR) antagonist
Sponsors & Collaborators
-
BioAtla, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-13
- Primary Completion
- 2025-09-22
- Completion
- 2025-09-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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