PK Assessment: Cmax of ARC101During the intervention/study therapy administration, approximately 1 year on average.
Measurement of Maximum Observed Concentration
PK Assessment: Cmin of ARC101During the intervention/study therapy administration, approximately 1 year on average.
Measurement of Minimum Observed Concentration
PK Assessment: Tmax of ARC101During the intervention/study therapy administration, approximately 1 year on average.
Measurement of Time to Reach Maximum Concentration
PK Assessment: AUC of ARC101During the intervention/study therapy administration, approximately 1 year on average.
Area under the plasma concentration versus time curve
Overall Response RateDuring the intervention/study therapy administration, approximately 1 year on average.
Percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 and overall survival (OS)
Duration of ResponseDuring the intervention/study therapy administration, approximately 1 year on average.
Time from first objective response to disease progression per RECIST 1.1 or death to any cause
Progression-Free SurvivalDuring the intervention/study therapy administration, approximately 1 year on average.
PFS is defined as the time from the start of the treatment until objective disease progression per PFS is defined as the time from the start of the treatment until objective disease progression per RECIST 1.1 or death from any cause
Number of anti-drug antibody (ADA) Positive ParticipantsDuring the intervention/study therapy administration, approximately 1 year on average.
Immunogenicity will be measured by the number of participants that are ADA positive.