Study Stopped
Terminated due to Oncorus portfolio reprioritization
Study of ONCR-177 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
A Phase 1, Open-Label, Multicenter, 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
2 other identifiers
interventional
66
2 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started May 2020
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedStudy Start
First participant enrolled
May 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedJune 8, 2023
June 1, 2023
3 years
April 13, 2020
June 6, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Percentage of Dose-Limiting Toxicities (DLTs)
Percentage of subjects with DLTs
From Day 1 up to 30 days after last dose
Percentage of Adverse Events (AEs)
Percentage of subjects with AEs
From Day 1 up to 30 days after last dose
Percentage of Serious Adverse Events (SAEs)
Percentage of subjects with SAEs
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
6 Months
Recommended Phase 2 Dose (RP2D) of ONCR-177
RP2D of ONCR-177 based on the data collected during dose escalation
6 Months
Secondary Outcomes (6)
Percentage of Objective Response Rate (ORR)
40 Months
Durable Response Rate (DRR)
40 Months
Progression Free Survival (PFS)
40 Months
Overall Survival (OS)
40 Months
Incidence and rate of detection of ONCR-177
6 Months
- +1 more secondary outcomes
Study Arms (6)
Dose escalation of ONCR-177 by intratumoral injection in subjects with surface lesions
EXPERIMENTALDose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors
Dose expansion of ONCR-177 in subjects with surface lesions
EXPERIMENTALDose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors
Dose expansion of ONCR-177 and pembrolizumab in subjects with surface lesions
EXPERIMENTALDose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors
Dose escalation of ONCR-177 by intratumoral injection in subjects with liver metastases
EXPERIMENTALDose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory solid tumor cancer with liver metastases
Dose expansion of ONCR-177 by intratumoral injection in subjects with liver metastases
EXPERIMENTALDose expansion of ONCR-177 intratumoral injections alone at the recommended phase 2 dose (RP2D) in subjects with advanced and/or refractory solid tumor cancer with liver metastases
Dose expansion of ONCR-177 and pembrolizumab in subjects with liver metastases
EXPERIMENTALDose expansion of ONCR-177 intratumoral injections at the RP2D in combination with pembrolizumab in subjects with advanced and/or refractory solid tumor cancer with liver metastases
Interventions
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1
Anti-PD-1 monoclonal antibody
Eligibility Criteria
You may qualify if:
- Male or female ≥ 18 years of age
- Solid tumor cancer with at least one injectable cutaneous, subcutaneous or nodal tumor OR at least one injectable liver metastasis that can be visualized and injected under radiologic guidance
- Have advanced or metastatic solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or must have a disease for which no standard of care exists
- Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy radiotherapy, or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Must have adequate hematologic function in accordance with the study protocol
- Must have adequate hepatic function in accordance with the study protocol
- Must have adequate renal function in accordance with the study protocol
- Female subjects of reproductive potential must have a negative serum pregnancy test during Screening and a serum or urine pregnancy test must be re-confirmed as negative no more than 72 hours before starting study treatment. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent, during the study, and for 6 months (both females and males) following the last dose of study drug(s)
- Life expectancy of ≥ 3 months
- Expansion:
- Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
You may not qualify if:
- Subjects on current antiviral treatment for herpes virus infections
- Requires chronic or intermittent treatment with systemic antivirals
- Any systemic anti-cancer treatment (including investigational agents) within 4 weeks prior to the first dose of study drug
- Has received prior radiotherapy within 2 weeks of start of study treatment
- Myelosuppressive chemotherapy within 4 weeks of study treatment
- Prior checkpoint inhibitor therapy administered within 4 weeks of study treatment
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has not fully recovered from any effects of major surgery or not free of significant detectable infection
- Other active malignancy within the previous 3 years of first dose of study treatment
- Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
- Have had significant active cardiac disease within 6 months prior to the start of study treatment
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has received a live vaccine within 30 days prior to the first dose of study drug
- Are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oncorus, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (11)
City of Hope
Duarte, California, 91010, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio, 43210, United States
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee, 37203, United States
The University of Texas at Austin
Austin, Texas, 78701, United States
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Haines BB, Denslow A, Grzesik P, Lee JS, Farkaly T, Hewett J, Wambua D, Kong L, Behera P, Jacques J, Goshert C, Ball M, Colthart A, Finer MH, Hayes MW, Feau S, Kennedy EM, Lerner L, Queva C. ONCR-177, an Oncolytic HSV-1 Designed to Potently Activate Systemic Antitumor Immunity. Cancer Immunol Res. 2021 Mar;9(3):291-308. doi: 10.1158/2326-6066.CIR-20-0609. Epub 2020 Dec 22.
PMID: 33355229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Goldberg, MD
Oncorus, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 16, 2020
Study Start
May 20, 2020
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
June 8, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share