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

NOT ENROLLING
Protocol # :
19-621
Conditions
Adult Solid Tumor
Phase
I
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Park, Jong, Chul
Site Investigator
Matulonis, Ursula, A.
Park, Jong, Chul
Site Research Nurses
Bowes, Brittany, N.
Hindenach, Sarah
Hurley-Whalen, Christin
Keis, Rylee
Morrissey, Stephanie, C.
Noyes, Sarah, M.
Valles, Betsy, J.
Weigel, Susan

Trial 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 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.

Eligibility Requirements

Key Inclusion Criteria:

- Male or female patients ≥18 years of age who are HLA-A*02+ (performed during screening
locally or centrally, or based on documented historic test results)

- Histologically confirmed incurable or metastatic solid tumors that are HPV16+
(performed during screening locally or centrally, or based on documented historic test
results)

- 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 leukapheresis 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
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

- Systemic treatment with either corticosteroids (>10 mg of prednisone or the equivalent
per day) or other immunosuppressive medications within 14 days prior to 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

- Known active hepatitis B or hepatitis C, or active mycobacterium tuberculosis
infection

- 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

- Major surgery within 2 weeks of leukapheresis

19-621