Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Megadott ok: Corporate Decision
Key facts
- Where
- Aurora, Boston, Cincinnati, Duarte, Minneapolis, Nashville, Omaha és Scottsdale, Egyesült ÁllamokSee the 9 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- University of Colorado Anschutz Cancer PavillionAurora, Egyesült ÁllamokNo longer taking part
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- University of Cincinnati Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
- City of Hope Medical CenterDuarte, Egyesült ÁllamokNo longer taking part
- Masonic Cancer Center, University of MinnesotaMinneapolis, Egyesült ÁllamokNo longer taking part
- Tennessee Oncology, PLLCNashville, Egyesült ÁllamokNo longer taking part
- Vanderbilt University Medical CenterNashville, Egyesült ÁllamokNo longer taking part
- University of Nebraska Medical CenterOmaha, Egyesült ÁllamokNo longer taking part
- Honor Health Research InstituteScottsdale, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- SQZ Biotechnologies
- Trial code
- NCT05357898
- Record updated
- 2024. február 23.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Patients must not have been treated with immune check-point inhibitors.
Exclusion: 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 >Grade 1 AEs related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except Grade 2 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement; Major surgery within 2 weeks of leukapheresis; History of any Grade 3 immune-related AE (irAE) from prior immunotherapy; Prior treatment with an immune check-point inhibitor; Patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the Sponsor; Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection; Have active interstitial lung disease and any history of myocarditis; Known hypersensitivity to pembrolizumab; Has known active central nervous system metastases.