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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

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ClinicalTrials.gov Identifier: NCT04348916
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Oncorus, Inc.

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.

Condition or disease Intervention/treatment Phase
Cancer Melanoma Solid Tumor Squamous Cell Carcinoma of Head and Neck Breast Cancer Advanced Solid Tumor Triple Negative Breast Cancer Colorectal Carcinoma Non-melanoma Skin Cancer Liver Metastases Biological: ONCR-177 Biological: pembrolizumab Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : July 2028

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: Dose escalation of ONCR-177 by intratumoral injection in subjects with surface lesions
Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors
Biological: ONCR-177
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1

Experimental: Dose expansion of ONCR-177 in subjects with surface lesions
Dose 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
Biological: ONCR-177
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1

Experimental: Dose expansion of ONCR-177 and pembrolizumab in subjects with surface lesions
Dose 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
Biological: ONCR-177
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1

Biological: pembrolizumab
Anti-PD-1 monoclonal antibody
Other Names:
  • MK-3475
  • KEYTRUDA

Experimental: Dose escalation of ONCR-177 by intratumoral injection in subjects with liver metastases
Dose escalation of ONCR-177 intratumoral injections alone in four cohorts in subjects with advanced and/or refractory solid tumor cancer with liver metastases
Biological: ONCR-177
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1

Experimental: Dose expansion of ONCR-177 by intratumoral injection in subjects with liver metastases
Dose 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
Biological: ONCR-177
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1

Experimental: Dose expansion of ONCR-177 and pembrolizumab in subjects with liver metastases
Dose 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
Biological: ONCR-177
Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1

Biological: pembrolizumab
Anti-PD-1 monoclonal antibody
Other Names:
  • MK-3475
  • KEYTRUDA




Primary Outcome Measures :
  1. Percentage of Dose-Limiting Toxicities (DLTs) [ Time Frame: From Day 1 up to 30 days after last dose ]
    Percentage of subjects with DLTs

  2. Percentage of Adverse Events (AEs) [ Time Frame: From Day 1 up to 30 days after last dose ]
    Percentage of subjects with AEs

  3. Percentage of Serious Adverse Events (SAEs) [ Time Frame: From Day 1 up to 90 days after last dose ]
    Percentage of subjects with SAEs

  4. Maximum Tolerated Dose (MTD) of ONCR-177 [ Time Frame: 6 Months ]
    MTD on the data collected during dose escalation

  5. Recommended Phase 2 Dose (RP2D) of ONCR-177 [ Time Frame: 6 Months ]
    RP2D of ONCR-177 based on the data collected during dose escalation


Secondary Outcome Measures :
  1. Percentage of Objective Response Rate (ORR) [ Time Frame: 40 Months ]
    Percentage of ORR

  2. Durable Response Rate (DRR) [ Time Frame: 40 Months ]
    DRR (continuous CR or PR ≥6 months)

  3. Progression Free Survival (PFS) [ Time Frame: 40 Months ]
    Duration of PFS for subjects

  4. Overall Survival (OS) [ Time Frame: 40 Months ]
    OS rate for subjects

  5. Incidence and rate of detection of ONCR-177 [ Time Frame: 6 Months ]
    Data gathered from blood, urine, swabs of injection site, dressings, and oral mucosa to determine the shedding and biodistribution of ONCR-177

  6. Changes in the level of HSV-1 antibodies compared to baseline [ Time Frame: From Day 1 up to last dose of ONCR-177 (up to 5 months) ]
    Change in HSV-1 antibody levels during treatment compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348916


Contacts
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Contact: Oncorus ONCR-177-101 1-617-665-5063 ONCR-177-101@oncorus.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
United States, Ohio
The Ohio State University Wexner Medical Center James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
United States, Tennessee
Sarah Cannon Research Institute - Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
The University of Texas at Austin Recruiting
Austin, Texas, United States, 78701
Canada, Ontario
University Health Network, Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Oncorus, Inc.
Merck Sharp & Dohme Corp.
Investigators
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Study Director: John Goldberg, MD Oncorus, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oncorus, Inc.
ClinicalTrials.gov Identifier: NCT04348916    
Other Study ID Numbers: ONCR-177-101
KEYNOTE-B73 ( Other Identifier: Merck Sharp & Dohme Corp )
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Triple Negative Breast Neoplasms
Liver Neoplasms
Skin Neoplasms
Colorectal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Squamous Cell
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents