Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Sandip Patel, MD
Photo of Sandip Patel
Sandip Patel

Description

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.

Official Title

A Phase 1, Multicenter, Open-Label Study of SQZ-AAC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitors in HLA-A*02+ Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Keywords

Adult Solid Tumor solid tumors cancer metastatic locally advanced cancer cervical head and neck anal penile SQZ-AAC-HPV HPV16 AAC cell therapy ipilimumab nivolumab checkpoint inhibitors immunotherapy solid tumor HLA-A*02 therapeutic vaccine Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • 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

You CAN'T join if...

  • 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

Location

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Sandip Patel, MD
    Associate Clinical Professor, Medicine. Authored (or co-authored) 35 research publications. Research interests: cancer immunotherapy · phase 1 clinical trials · cellular therapy · immunometabolism · microbiome · IDO · personalized medicine · precision medicine · CAR-T cell · NK cell · proteomics · immunotherapy.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SQZ Biotechnologies
ID
NCT04892043
Phase
Phase 1
Study Type
Interventional
Last Updated