Breast Cancer Clinical Trial
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
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.
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.
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
•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
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There are 11 Locations for this study
Duarte California, 91010, United States
Denver Colorado, 80218, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Buffalo New York, 14263, United States
Columbus Ohio, 43210, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78701, United States
Toronto Ontario, M5G 2, Canada
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