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

Last updated: June 6, 2023
Sponsor: Oncorus, Inc.
Overall Status: Terminated

Phase

1

Condition

Liver Cancer

Primary Biliary Cholangitis

Cancer/tumors

Treatment

ONCR-177

pembrolizumab

Clinical Study ID

NCT04348916
ONCR-177-101
KEYNOTE-B73
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female ≥ 18 years of age
  • Solid tumor cancer with at least one injectable cutaneous, subcutaneous or nodal tumorOR at least one injectable liver metastasis that can be visualized and injected underradiologic 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 diseasefor which no standard of care exists
  • Be fully recovered from major surgery and from the acute toxic effects of priorchemotherapy 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 testduring Screening and a serum or urine pregnancy test must be re-confirmed as negativeno more than 72 hours before starting study treatment. Females of reproductivepotential as well as fertile men with partners who are female of reproductivepotential must agree to abstain from sexual intercourse or to use 2 effective forms ofcontraception (including at least 1 barrier form) from the time of giving informedconsent, during the study, and for 6 months (both females and males) following thelast 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

Exclusion

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 weeksprior 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 investigationalagent or has used an investigational device within 4 weeks prior to the first dose ofstudy treatment.
  • Has not fully recovered from any effects of major surgery or not free of significantdetectable 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 carcinomatousmeningitis
  • Have had significant active cardiac disease within 6 months prior to the start ofstudy 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

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: ONCR-177
Phase: 1
Study Start date:
May 20, 2020
Estimated Completion Date:
May 31, 2023

Study 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.

Connect with a study center

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Sarah Cannon Research Institute - Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • The University of Texas at Austin

    Austin, Texas 78701
    United States

    Site Not Available

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