Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
- Conditions
- Adult Solid Tumor
- Registration Number
- NCT05357898
- Lead Sponsor
- SQZ Biotechnologies
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0 Through 6 weeks after the patient's last dose of investigational product For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Number of participants with dose-limiting toxicity (DLT) Through Day 42 For SQZ-eAPC-HPV in combination with pembrolizumab (Part 1B).
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product Proportion of patients with best response of complete response \[CR\] and/or partial response \[PR\] as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Best overall response (BoR) Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product Evaluation of the BoR defined as CR, PR, Stable Disease \[SD\], Progressive Disease \[PD\] or Not Evaluable \[NE\] as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Progression-free survival (PFS) Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product Defined as the time from first dose of study treatment to first overall response of PD by RECIST v 1.1 or to death by any cause. This will be censored at the last RECIST v1.1 assessment if PD/death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Duration of Response (DoR) Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product Defined as the time from overall response of CR or PR to first overall response of PD by RECIST v1.1 or to death by any cause. This is defined only for patients who have a CR or PR and will be censored at the last RECIST v1.1 assessment if PD/Death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Disease-control rate (DCR) Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product Proportion of patients with best response of CR or PR or SD as defined by RECIST v1.1 criteria. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Overall survival (OS) Through study completion, up to 2 years Defined as the time from first dose of study treatment to death by any cause. This will be censored at the last date patient is known to be alive if death is not observed. For SQZ-eAPC-HPV as a monotherapy, in combination with pembrolizumab, and as a monotherapy lead-in with pembrolizumab (Part 1A, Part 1B, and Part 2, respectively).
Amount of investigational product (IP) from individual patient blood collection - batch yield From leukapheresis through manufacture, a maximum of 28 days To determine manufacturing feasibility as assessed by batch yield (number of manufacturing runs)
Amount of investigational product (IP) from individual patient blood collection - product failures From leukapheresis through manufacture, a maximum of 28 days To determine manufacturing feasibility as assessed by number of product failures
Trial Locations
- Locations (9)
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
University of Colorado Anschutz Cancer Pavillion
🇺🇸Aurora, Colorado, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Honor Health Research Institute🇺🇸Scottsdale, Arizona, United States