3 results
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
The purpose of this first-in-human (FIH) study is to assess the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (single ascending dose [SAD] - Part A) as well as in…
Primary objective:To compare Arm A relative to Arm B on event-free survival (EFS)Key secondary objectives:- To compare Arm A relative to Arm B on overall survival (OS)- To compare Arm A relative to Arm B on pathological complete response (pCR) rate