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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2024
  • participants needed
    72
  • sponsor
    SQZ Biotechnologies
Updated on 24 November 2021

Summary

This is a Phase 1 open-label, multicenter study of the safety and tolerability, immunogenic effects, antitumor activity, and pharmacodynamics of SQZ-AAC-HPV as monotherapy and in combination with 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.

Details
Condition Adult Solid Tumor
Treatment Ipilimumab, Nivolumab, SQZ-AAC-HPV
Clinical Study IdentifierNCT04892043
SponsorSQZ Biotechnologies
Last Modified on24 November 2021

Eligibility

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
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)
Patients must agree to venous access for the blood draw and be willing to have a central line inserted if venous access is an issue
Adequate organ function and bone marrow reserve performed within 14 days prior to the blood draw

Exclusion Criteria

Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to blood draw. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to Cycle 1 Day 1
Systemic treatment with either corticosteroids (>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to Cycle 1 Day 1
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 blood draw, except Grade 2 alopecia
Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
History of any Grade 4 immune-related AE (irAE) from prior immunotherapy
Has known active central nervous system metastases
History of interstitial lung disease requiring steroids
Significant acute or chronic illness
Major surgery within 2 weeks of blood draw
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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