ONCR-177-101 is a phase 1, open-label, multi-center, dose escalation and expansion study of ONCR-177, an oncolytic Herpes Simplex Virus for intratumoral injection, alone and in combination with PD-1 blockade in adult subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with Liver Metastases of Solid Tumors. The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
ONCR-177 is an intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1 (herpes simplex virus type 1) that selectively replicates in tumor tissue. Oncorus Inc. is developing ONCR-177 both as monotherapy and in combination with PD-1 blockade for the treatment of advanced solid tumor malignancies. This first-in-human (FIH) Phase 1 dose escalation and expansion study will determine the intratumoral dose of ONCR-177 as a monotherapy and in combination with pembrolizumab, in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with Liver Metastases of Solid Tumors. This protocol will enroll subjects who have at least one lesion that is visible, palpable or detectable and can be injected, and subjects who have liver metastases of solid tumors. Subjects with any cancer types who are eligible for the trial and have such lesions can be considered for enrollment. Additionally, preliminary evidence for clinical and immunologic activity will be sought to guide ongoing studies and development of ONCR-177 in subjects with cancers that are unmet medical needs. Confirmation of safety of ONCR-177 administration in combination with pembrolizumab will also be evaluated in this study, to enable development as part of combination immunotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1
Anti-PD-1 monoclonal antibody
City of Hope
Duarte, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, United States
The University of Texas at Austin
Austin, Texas, United States
...and 1 more locations
Percentage of Dose-Limiting Toxicities (DLTs)
Percentage of subjects with DLTs
Time frame: From Day 1 up to 30 days after last dose
Percentage of Adverse Events (AEs)
Percentage of subjects with AEs
Time frame: From Day 1 up to 30 days after last dose
Percentage of Serious Adverse Events (SAEs)
Percentage of subjects with SAEs
Time frame: From Day 1 up to 90 days after last dose
Maximum Tolerated Dose (MTD) of ONCR-177
MTD on the data collected during dose escalation
Time frame: 6 Months
Recommended Phase 2 Dose (RP2D) of ONCR-177
RP2D of ONCR-177 based on the data collected during dose escalation
Time frame: 6 Months
Percentage of Objective Response Rate (ORR)
Percentage of ORR
Time frame: 40 Months
Durable Response Rate (DRR)
DRR (continuous CR or PR ≥6 months)
Time frame: 40 Months
Progression Free Survival (PFS)
Duration of PFS for subjects
Time frame: 40 Months
Overall Survival (OS)
OS rate for subjects
Time frame: 40 Months
Incidence and rate of detection of ONCR-177
Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of ONCR-177
Time frame: 6 Months
Changes in the level of HSV-1 antibodies compared to baseline
Change in HSV-1 antibody levels during treatment compared to baseline
Time frame: From Day 1 up to last dose of ONCR-177 (up to 5 months)
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