Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Overview

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.

Full Title of Study: “A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2022

Interventions

  • Biological: SQZ-PBMC-HPV
    • antigen presenting cell therapy; therapeutic vaccine consisting of autologous peripheral blood mononuclear cells (PBMCs) presenting immunogenic epitopes of the E6 and E7 proteins of HPV16
  • Drug: Atezolizumab
    • programmed cell death ligand 1 (PD-L1) blocking antibody

Arms, Groups and Cohorts

  • Experimental: Dose escalation of SQZ-PBMC-HPV
    • In the monotherapy escalation cohorts, SQZ-PBMC-HPV is given for up to 3 administrations at intervals of 3 weeks as a low and a high cell dose. In addition, a second low cell dose cohort will test the impact of additional vaccination boosts of SQZ-PBMC-HPV.
  • Experimental: Dose escalation of SQZ-PBMC-HPV + atezolizumab
    • In the combination escalation cohorts, SQZ-PBMC-HPV in combination with atezolizumab is given for up to 3 administrations at intervals of 3 weeks as a low and a high cell dose. In addition, a second low cell dose cohort will test the impact of additional vaccination boosts of SQZ-PBMC-HPV given in combination with atezolizumab. Participants may continue to receive atezolizumab study drug every 3 weeks for a maximum of 1 year or until discontinuation criteria are met.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
    • Time Frame: approximately 10 months
    • For SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
  • Maximum tolerated dose (MTD)
    • Time Frame: approximately 6 weeks
    • MTD of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
  • Recommended Phase 2 dose (RP2D)
    • Time Frame: approximately 10 months
    • RP2D of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab

Secondary Measures

  • Number of patients with development of endogenous immune responses via ELISPOT in CD8 T cells
    • Time Frame: Up to 1 year
    • Immunogenic effects on peripheral blood cells of SQZ-PBMC-HPV as a single agent and in combination with atezolizumab
  • Antitumor activity
    • Time Frame: Up to 1 year
    • Tumor assessments using RECIST 1.1 of SQZ PBMC-HPV monotherapy and in combination with atezolizumab
  • Number of patients with change in blood cytokine levels
    • Time Frame: Up to 1 year
    • SQZ-PBMC-HPV as a single agent and in combination with atezolizumab

Participating in This Clinical Trial

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
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1
  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • SQZ Biotechnologies
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Nicole D’Auteuil, 978-758-9060, nicole.dauteuil@sqzbiotech.com

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