Summary
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and
in China. The purpose of this study is to assess adverse events disease activity when
comparing intravenously (IV) infused ABBV-400 to trifluridine and tipiracil (LONSURF)
oral tablets plus IV infused bevacizumab in adult participants with c-Met over-expressed
refractory metastatic colorectal cancer (mCRC).
ABBV-400 is an investigational drug being developed for the treatment of CRC.
Participants are put into treatment arms as part of 2 stages. Each treatment arm in stage
1 receives a different dose of ABBV-400. Each treatment arm in stage 2 receives the
optimal dose of ABBV-400 or LONSURF plus bevacizumab. Up to approximately 460 adult
participants with c-Met over-expressed (OE) refractory mCRC, will be enrolled in the
study in approximately 160 sites in 15-20 countries.
In stage 1, participants will receive intravenously (IV) infused ABBV-400 dose A or B. In
stage 2, participants will receive the optimal dose of IV infused ABBV-400 or the
standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. The total study
duration will be approximately 4 years.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits 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.