Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
Study of SQZ-eAPC-HPV 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.
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.
Not Available
Phase I/II
Adults
Mol. targeted/Immunotherapy/Biologics
MK-3475,
Pembrolizumab (MK-3475),
SQZ-eAPC-HPV
Iams, Wade
International
Vanderbilt University
03-15-2023
Treatment
VICCPHI2264
NCT05357898
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
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
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
