A Phase 2 Study of Ozuriftamab Vedotin in People With Advanced Head and Neck Cancer

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Full Title

A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in PD-1/L1 Failure Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Purpose

The purpose of this study is to see how well ozuriftamab vedotin works in people with head and neck cancer. The people in this study have cancer that keeps growing even after immunotherapy. The cancers also have a protein called ROR2. ROR2 is normally involved in bone development, but it is also found on the surface of some cancer cells.

Ozuriftamab vedotin attaches to the surface of cancer cells. Once it binds to these cells, it releases a chemotherapy drug to kill them. Ozuriftamab vedotin is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have head and neck cancer that came back or spread (metastasized) even after anti-PD-1 immunotherapy. These cancers include oropharynx, oral cavity, hypopharynx, and larynx cancer. Examples of anti-PD-1 immunotherapy include pembrolizumab or nivolumab.
  • Have a tumor that has the ROR2 protein.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Winston Wong’s office at 646-608-4245

Protocol

23-045

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05271604