Study Comparing IV Infused ABBV-400 to Oral LONSURF and IV Bevacizumab in Adults with Advanced Colorectal Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT06614192
This clinical trial is testing a new drug, ABBV-400, against a standard treatment of LONSURF and bevacizumab in adults with advanced colorectal cancer that has not responded to previous treatments and shows high levels of c-Met protein.
Patient Parameters
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Program Overview
Colorectal cancer is a common cancer worldwide. This study aims to compare the effects and side effects of a new drug, ABBV-400, given through an IV, with a standard treatment of LONSURF tablets and bevacizumab IV in adults with advanced colorectal cancer that has not responded to other treatments and has high levels of a protein called c-Met. The study will involve about 460 participants across 160 sites in 15-20 countries. Participants will be divided into groups to receive different doses of ABBV-400 or the standard treatment. The study will last about 4 years, and participants will have regular check-ups, including medical exams, blood tests, and questionnaires to monitor the treatment's effects and any side effects.
Eligibility Criteria
Inclusion Criteria
- Expected to live at least 12 more weeks according to the doctor.
- In good general health, able to carry out normal activities or light work.
- Have cancer that can be measured by scans or tests.
Exclusion Criteria
- Have previously received treatments targeting c-MET or similar drugs.
- Have had allergic reactions to bevacizumab or similar drugs.
- Have an active infection as specified in the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center /ID# 267875 | 91010 | Duarte | California |
| City of Hope Orange County Lennar Foundation Cancer Center /ID# 270655 | 92618 | Irvine | California |
| USC Norris Comprehensive Cancer Center /ID# 268131 | 90033 | Los Angeles | California |
| Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175 | 80401 | Golden | Colorado |
| Yale New Haven Hospital /ID# 269125 | 06510 | New Haven | Connecticut |
| AdventHealth Orlando /ID# 267970 | 32803 | Orlando | Florida |
| St. Luke's Cancer Institute: Boise /ID# 268095 | 83712 | Boise | Idaho |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 268610 | 60611-2927 | Chicago | Illinois |
| Hope And Healing Cancer Services /ID# 268541 | 60521 | Hinsdale | Illinois |
| Springfield Clinic /ID# 268666 | 62702-3749 | Springfield | Illinois |
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