A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer

This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.

Inclusion Criteria:
• Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable, recurrent disease. confirmed by cytogenetics.
• Checkpoint inhibitor naïve and may have received prior platinum containing chemotherapy regimen.
• Measurable disease according to RECIST v1.1.
• HLA-A*02 positive
• Tumor shows MAGE-A4 expression confirmed by central laboratory.
• Tumors express PD-L1 [CPS ≥1]
• Left ventricular ejection fraction (LVEF) ≥50%.
• Note: other protocol defined Inclusion criteria may apply

Exclusion Criteria:
• Positive for any HLA-A*02 allele other than: one of the inclusion alleles, HLA-A*02:07P or HLA-A*02 null alleles
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study or history of severe hypersensitivity to another monoclonal antibody.
• History of autoimmune or immune mediated disease
• Leptomeningeal disease, carcinomatous meningitis or CNS metastases.
• Other prior malignancy that is not considered by the Investigator to be in complete remission
• Clinically significant cardiovascular disease
• Uncontrolled intercurrent illness
• Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
• Note: other protocol defined Exclusion criteria may apply.
Phase II
Oral, Head and Neck
Rom Leidner, M.D.
George Morris
  • Providence Cancer Institute Franz Clinic