A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination with Atezolizumab or Other Immune Checkpoint Inhibitors in HLA-A*02+ Patients with HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-PBMC-HPV as monotherapy and in combination with atezolizumab in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors.

Inclusion Criteria:
• Male or female patients ≥18 years of age who are HLA-A*02
• Histologically confirmed incurable or metastatic solid tumors that are HPV16+
• Cancer must have progressed after at least 1 available standard therapy for incurable disease, or the patient is intolerant to or refuses standard therapy(ies) or has a tumor for which no standard therapy(ies) exist
• At least 1 measurable lesion according to RECIST 1.1

Exclusion Criteria:
• Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis
• Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
• History of any Grade 4 immune-related AE (irAE) from prior immunotherapy
• Significant acute or chronic illness
• Major surgery within 2 weeks of leukapheresis
Phase I
Multiple Tumor Types
Matthew Taylor, M.D.
SQZ Biotechnologies
Anne Stadum
  • Providence Cancer Institute Franz Clinic