Phase
Condition
Liver Cancer
Primary Biliary Cholangitis
Cancer/tumors
Treatment
ONCR-177
pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United StatesSite Not Available
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesSite Not Available
The Ohio State University Wexner Medical Center James Cancer Hospital
Columbus, Ohio 43210
United StatesSite Not Available
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
The University of Texas at Austin
Austin, Texas 78701
United StatesSite Not Available

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