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
This 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.
To assess the safety and tolerability of ONCR-177 alone and in
combination with PD-1 blockade
To determine the maximum feasible, safe and tolerated dose (MTD) and/or
the Recommended Phase 2 Dose (RP2D) of ONCR-177 for intratumoral
injections alone and in combination with PD-1 blockade in subjects with
cutaneous, subcutaneous or metastatic nodal tumors
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
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