Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (NCT04084951) | Clinical Trial Compass
CompletedPhase 1
Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
United States30 participantsStarted 2020-01-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 immunosuppre…
What they're measuring
1
Number of participants with treatment-related 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
2
Number of participants with dose-limiting toxicity (DLT)
Timeframe: Up to 1 year after LPFV
3
Objective response rate (ORR) [Part 3]
Timeframe: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
4
Best overall response (BoR) [Part 3]
Timeframe: Through start of a new anticancer therapy, up to 2 years after the first dose of investigational product]
5
Progression-free survival (PFS) [Part 3]
Timeframe: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product
6
Duration of Response (DoR) [Part 3]
Timeframe: Through progression per RECIST v1.1 or start of new anticancer therapy, up to 2 years after first dose of investigational product