Clinical trial NCT05357898: Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, First-in-Human, Multicenter, Open-Label Study of SQZ-eAPC-HPV as Monotherapy and in Combination With Immune Checkpoint Inhibitor(s) in Patients With HPV16+ Recurrent, Locally Advanced, or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Adult Solid Tumor
Keywords: recurrent cancer
metastatic
locally advanced
cancer
head and neck cancer
cervical
anal
vulvar
penile
SQZ-eAPC-HPV
HPV16
human papillomavirus 16
eAPC
enhanced antigen presenting cells
cell therapy
pembrolizumab
checkpoint inhibitors
immunotherapy
solid tumor
therapeutic vaccine
advanced solid tumor
throat cancer
Lead sponsor: SQZ Biotechnologies
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.


Eligibility criteria: Inclusion Criteria - All Patients:

* Male or female patients ≥18 years of age
* Histologically confirmed incurable or metastatic solid tumors that are HPV16+ (performed during screening locally or centrally, or based on documented historic test results)
* 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 Screening and on Cycle 2 Day 8 (+/- 2 days)
* Patients must agree to venous access for 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 leukapheresis

Inclusion Criteria - Part 2:

• Patients must not have been treated with immune check-point inhibitors

Exclusion Criteria - All Patients:

* Treatment with anticancer therapy, including investigational therapy, within 2 weeks 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 prior to leukapheresis
* 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 Grade 2 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement
* Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
* Has known active central nervous system metastases
* Have active interstitial lung disease and any history of myocarditis
* Major surgery within 2 weeks of leukapheresis

Exclusion Criteria - Part 1B:

* Known hypersensitivity to pembrolizumab
* History of any Grade 3 immune-related AE (irAE) from prior immunotherapy

Exclusion Criteria - Part 2:

• Prior treatment with an immune check-point inhibitor

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
timeFrame: Through 6 weeks after the patient's last dose of investigational product
measure: Number of participants with dose-limiting toxicity (DLT)
timeFrame: Through Day 28
measure: Number of participants with dose-limiting toxicity (DLT)
timeFrame: Through Day 42
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
measure: Best overall response (BoR)
timeFrame: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product
measure: Progression-free survival (PFS)
timeFrame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
measure: Duration of Response (DoR)
timeFrame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
measure: Disease-control rate (DCR)
timeFrame: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
measure: Overall survival (OS)
timeFrame: Through study completion, up to 2 years
measure: Amount of investigational product (IP) from individual patient blood collection - batch yield
timeFrame: From leukapheresis through manufacture, a maximum of 28 days
measure: Amount of investigational product (IP) from individual patient blood collection - product failures
timeFrame: From leukapheresis through manufacture, a maximum of 28 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Cancer Pavillion
state: Colorado
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: