Status:
TERMINATED
Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
SQZ Biotechnologies
Conditions:
Adult Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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 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
- Known HIV infection, active hepatitis B or hepatitis C, or active mycobacterium tuberculosis infection
- Has known active central nervous system metastases
- Have active interstitial lung disease and any history of myocarditis
- Major surgery within 2 weeks of leukapheresis
- Exclusion Criteria - Part 1B:
- Known hypersensitivity to pembrolizumab
- History of any Grade 3 immune-related AE (irAE) from prior immunotherapy
- Exclusion Criteria - Part 2:
- • Prior treatment with an immune check-point inhibitor
Exclusion
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05357898
Start Date
March 24 2022
End Date
November 27 2023
Last Update
February 23 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
2
City of Hope Medical Center
Duarte, California, United States, 91010
3
University of Colorado Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80045
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114