Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (NCT05357898) | Clinical Trial Compass
TerminatedPhase 1/2
Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Stopped: Corporate Decision
United States20 participantsStarted 2022-03-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treat…
What they're measuring
1
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
2
Number of participants with dose-limiting toxicity (DLT)
Timeframe: Through Day 28
3
Number of participants with dose-limiting toxicity (DLT)