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

  • days left to enroll
  • participants needed
  • sponsor
    SQZ Biotechnologies
Updated on 19 September 2022
measurable disease
solid tumour


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 or other immune checkpoint inhibitors in HLA-A*02+ patients with recurrent, locally advanced or metastatic human papillomavirus strain 16 positive (HPV16+) solid tumors. The study includes patients with anal, rectal, cervical, head and neck, penile, vulvar, or vaginal cancer.

Condition Adult Solid Tumor
Treatment Ipilimumab, Nivolumab, Atezolizumab, SQZ-PBMC-HPV
Clinical Study IdentifierNCT04084951
SponsorSQZ Biotechnologies
Last Modified on19 September 2022


Yes No Not Sure

Inclusion Criteria

Male or female patients ≥18 years of age who are HLA-A02+
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
Patients must agree to venous access for the leukapheresis and be willing to have a central line inserted if venous access is an issue
Must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at Baseline and on Cycle 2 Day 8 (+/- 3 days)
Adequate organ function and bone marrow reserve performed within 14 days prior to the leukapheresis

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
Systemic treatment with either corticosteroids (>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis
Major surgery within 2 weeks of leukapheresis
Patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months may not be eligible and should be discussed with the Sponsor
Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor
Patients with >Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
Has known active central nervous system metastases
History of interstitial lung disease requiring steroids
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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