Phase 3 Study Comparing Precemtabart Tocentecan With or Without Bevacizumab Versus TrifluridineTipiracil Plus Bevacizumab in Adults With Metastatic Colorectal Cancer Previously Treated

What this Trial Is About

Researchers are evaluating treatments for people with metastatic colorectal cancer mCRC who have already received certain standard therapies including irinotecan, oxaliplatin, fluoropyrimidine, and bevacizumab. The study aims to see if treatment with precemtabart tocentecan Precem-TcT, alone or combined with bevacizumab, can prolong overall survival compared to the combination of trifluridinetipiracil FTD-TPI plus bevacizumab. This is a randomized, open-label Phase 3 clinical trial investigating these options for previously treated mCRC patients. Participants are randomly assigned to one of three groups Precem-TcT alone given intravenously once every 3 weeks in 21-day cycles Precem-TcT combined with bevacizumab, where bevacizumab is administered intravenously every 3 weeks or every 2 weeks depending on the cycle schedule or FTD-TPI plus bevacizumab, with FTD-TPI given orally twice daily on specified days in 28-day cycles. The study observes treatment effects while participants receive these medications according to their assigned group. During the trial, participants will be regularly assessed for overall survival and disease progression over about 19 months. Researchers will also monitor tumor response, duration of response, adverse events, drug concentrations, immune response to the drugs, and quality of life using questionnaires. These assessments include clinical evaluations and laboratory tests conducted at scheduled intervals throughout treatment. Participants remain under close medical monitoring to track treatment impact and safety until the studys end.

A 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)