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

ONCR-177-101

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.

2020-05-20

2023-05-31

2023-05-31

Terminated

Early phase I

66

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

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2023-06-08