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Trial record 1 of 1 for:    NCT04348916
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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

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ClinicalTrials.gov Identifier: NCT04348916
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Oncorus, Inc.

Study Description
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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. 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 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. This protocol will enroll subjects who have at least one lesion that is visible, palpable or detectable and can be injected. 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 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
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation of ONCR-177 by intratumoral injection
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 solid tumors
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: ONCR-177 and pembrolizumab in subjects with solid tumors
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: pembrolizumab
Anti-PD-1 monoclonal antibody
Other Name: KEYTRUDA


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects with Dose-Limiting Toxicities (DLTs) During the First 28 Days of Treatment [ Time Frame: 28 Days ]
  2. Percentage of Subjects with Adverse Events and Serious Adverse Events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR), based on RECIST v1.1, as well as Durable Response Rate (DRR) (continuous CR or PR ≥6 months), Progression Free Survival (PFS), and Overall Survival (OS) [ Time Frame: 40 months ]
  2. Incidence of ONCR-177 detection [ Time Frame: 40 months ]
    Blood, urine, swabs of injection site, dressing, oral mucosa

  3. Changes in the level of anti-HSV-1 antibodies compared to baseline [ Time Frame: 40 months ]

Eligibility Criteria
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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
  • 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
Contacts and Locations
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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, Tennessee
Sarah Cannon Research Institute - Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Oncorus, Inc.
Investigators
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Study Director: John Goldberg, MD Oncorus, Inc.
More Information
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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
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
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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Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms by Histologic Type
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
 Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents