2 results
Approved WMOCompleted
Cohort 1 (HER2-positive/amplified MBC): MCLA-128 + trastuzumab ± vinorelbine Primary objective:• Evaluate efficacy of MCLA-128 combined with trastuzumab ± vinorelbine in terms of clinical benefit rate (CBR) at 24 weeks based on RECIST 1.1 (per…
Approved WMORecruiting
Primary objectives:Safety:To demonstrate the safety of the investigational device in 10 subjects at 3 months post-surgery.Safety cohort data will be pooled with the performance cohort data, to measure the performance and safety of the…