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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.
Primary 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
ONCR-177 (); Pembrolizumab (Keytruda)