Clinical Trials /

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

NCT04084951

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: SQZ-PBMC-HPV-101
  • NCT ID: NCT04084951

Conditions

  • Adult Solid Tumor

Interventions

DrugSynonymsArms
SQZ-PBMC-HPVDose escalation of SQZ-PBMC-HPV
AtezolizumabDose escalation of SQZ-PBMC-HPV + atezolizumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation of SQZ-PBMC-HPVExperimentalIn 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.
  • SQZ-PBMC-HPV
Dose escalation of SQZ-PBMC-HPV + atezolizumabExperimentalIn 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.
  • SQZ-PBMC-HPV
  • Atezolizumab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Time Frame:approximately 10 months
Safety Issue:
Description:For SQZ-PBMC-HPV as a single agent and in combination with atezolizumab

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:SQZ Biotechnologies

Trial Keywords

  • Solid tumors cancer
  • metastatic
  • locally advanced
  • cancer
  • cervical
  • head and neck
  • anal
  • penile
  • SQZ-PBMC-HPV
  • atezolizumab
  • HPV16
  • APC
  • cell therapy

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