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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adult Solid Tumor
- Sponsor
- SQZ Biotechnologies
- Enrollment
- 20
- Locations
- 9
- Primary Endpoint
- Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of participants with treatment-emergent adverse events (TEAEs; all, related, serious, and of special interest) as assessed by CTCAE version 5.0
Time Frame: 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)
Time Frame: Through Day 42
For SQZ-eAPC-HPV in combination with pembrolizumab (Part 1B).
Secondary Outcomes
- 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)
- Best overall response (BoR)(Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product)
- 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)
- 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)
- 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)
- Overall survival (OS)(Through study completion, up to 2 years)
- Amount of investigational product (IP) from individual patient blood collection - batch yield(From leukapheresis through manufacture, a maximum of 28 days)
- Amount of investigational product (IP) from individual patient blood collection - product failures(From leukapheresis through manufacture, a maximum of 28 days)