Education and Training
A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 in PD-1/L1 failure patients with ROR-2 expression in recurrent or metastatic squamous cell carcinoma of the head and neck.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Ozuriftamab Vedotin
- biological: PD-1 inhibitor
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV
and not amenable to local therapy with curative intent (surgery or radiation therapy
with or without chemotherapy). The eligible primary tumor locations are oropharynx,
oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of
nasopharynx (any histology).
- Documented treatment failure of no more than one approved PD-1/L1 inhibitor either
administered alone or in combination.
Patients must have measurable disease.
- Age ≥ 18 years
- Adequate renal function
- Adequate liver function
- Adequate hematological function
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as
well as known or suspected allergy or intolerance to any agent given during this
study.
- Patients must not have known human immunodeficiency virus (HIV) infection, active
hepatitis B and/or hepatitis C.
- Patients must not be women who are pregnant or breast feeding.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elizabeth (Elzbieta) Winters
650-721-6509
Not Recruiting