Summary
The purpose of this study is to assess adverse events and changes in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of metastatic colorectal cancer (mCRC). Fluorouracil and leucovorin are drugs approved for the treatment of mCRC.
This study will be divided into two stages.
The first stage (dose escalation) will be treating people with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX chemotherapy and bevacizumab targeted therapy, or 5FU/LV chemotherapy and panitumumab targeted therapy until the dose reached is tolerable and expected to be efficacious.
In the next stage (dose optimisation), participants will then be randomised into 3 groups called treatment arms where one group will receive one of two optimised doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX chemotherapy and bevacizumab targeted therapy, or with 5FU/LV chemotherapy and panitumumab targeted therapy, or a comparator of FOLFOX and bevacizumab or panitumumab.
The study will run for a duration of approximately 6 years.
There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visists during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.