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
Categories (click each to see list of all clinical trials associated with that category): GI (ONC), Gyn/Onc (OB/GYNONC), Thoracic (ONC)
Current Status: Open
Phase: I
Principal Investigator: Rodabaugh, Kerry
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04084951?cond=NCT04084951&draw=2&rank=1#eligibility
Summary
Escalation Phase:
Primary Objectives
To characterize the safety and tolerability of different doses of SQZ-PBMC-HPV
administered both as monotherapy and in combination with atezolizumab in human
leukocyte antigen A*02 positive (HLA-A*02+) patients with human papillomavirus
(HPV) type 16 positive (HPV16+) recurrent, locally advanced or metastatic solid
tumors.
To determine the maximum tolerated dose, if possible, and recommended Phase 2
dose (RP2D) regimen of SQZ-PBMC-HPV monotherapy and in combination with
atezolizumab.
Secondary Objectives
To assess the antitumor activity of SQZ-PBMC-HPV in patients with recurrent,
locally advanced or metastatic solid tumors.
To assess the dose manufacturing feasibility of SQZ-PBMC-HPV.
Exploratory Objectives
To explore changes in blood cytokines after treatment with SQZ-PBMC-HPV.
To characterize the immunogenic and pharmacodynamic effects (on selected
pharmacodynamic parameters) and duration of pharmacodynamic response
following SQZ-PBMC-HPV administration.
Expansion Phase:
Primary Objectives
To further evaluate the safety and tolerability of SQZ-PBMC-HPV as monotherapy
and in combination with atezolizumab.
To determine the antitumor activity 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.
Exploratory Objectives
To explore changes in blood cytokines during treatment with SQZ-PBMC-HPV.
To characterize the immunogenic and pharmacodynamic effects (on selected
pharmacodynamic parameters) and duration of pharmacodynamic response
following SQZ-PBMC-HPV administration.