NCT05271604

A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: BioAtla, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	Ozuriftamab Vedotin	Conditionally active biologic anti-ROR2 antibody drug conjugate
BIOLOGICAL	Pembrolizumab	PD-1 inhibitor
BIOLOGICAL	Evalstotug (BA3071)	Conditionally active biologic anti-CTLA-4 checkpoint blockade antibody
BIOLOGICAL	Cetuximab	Epidermal growth factor receptor (EGFR) antagonist

Timeline

• Start date: 2022-12-13
• Primary completion: 2025-09-22
• Completion: 2025-09-22
• First posted: 2022-03-09
• Last updated: 2025-09-26

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study