A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

简要总结

主要结局

次要结局

• Arm 1 and Arm 2: Overall Survival(Time from date of randomization to death, assessed approximately up to average of 19 months)
• Progression Free Survival (PFS)(Time from randomization to the first occurrence of disease progression or death, whichever occurs first (assessed up to average of 19 months))
• Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator(Up to average of 19 months)
• Duration of Response as Assessed by Investigator(Time from first documentation of objective response to PD or death (assessed up to average of 19 months))
• Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events(Up to average of 19 months)
• Observed Concentration at End of Infusion (CEOI) Period(At end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (each cycle is of 28 days))
• Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough)(At end of dosing interval on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1 until treatment discontinuation (assessed up to average of 19 months) (each cycle is of 28 days))
• Number of Participants with Anti-Drug Antibody as measured by ADA assay(Predose (-4 to 0 hours) on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 8 Day 1; thereafter every 4 cycles until treatment discontinuation (assessed up to average of 19 months) (each cycle is of 28 days))
• Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)(Arm 1 and 2:Cycle1Day 1(Baseline),Cycle1Day8,Cycle1Day15,Cycles2-6Day1,Cycles2-6Day15,Cycles more than equal to(>=)7Day1(each cycle is 21 days); Arm 3:Cycle1Day 1,Cycle 1 Day 8, Cycle 1 Day 15, Cycles >=2 Day 1, Cycles >=2 Day 15 (each cycle is 28 days))