Study on the Effects and Safety of ABBV-400 with Chemotherapy for Advanced Colorectal Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT06107413
This clinical trial is testing a new drug, ABBV-400, combined with chemotherapy drugs to see how safe it is and how it affects cancer activity in adults with advanced colorectal cancer that cannot be surgically removed.
Patient Parameters
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Program Overview
This study is exploring the safety and effects of a new drug called ABBV-400 when used with chemotherapy drugs Fluorouracil, Folinic Acid, and Bevacizumab in adults with advanced colorectal cancer that cannot be removed by surgery. ABBV-400 is an experimental drug, while the other drugs are already approved for this type of cancer. Participants will be divided into groups to receive different doses of ABBV-400 along with the chemotherapy drugs. The study will involve about 206 adults across 65 locations worldwide and will last approximately 3 years. Participants will have regular hospital or clinic visits for check-ups, blood tests, and to monitor any side effects.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced colorectal cancer that cannot be surgically removed.
- Have measurable cancer according to specific medical criteria.
Exclusion Criteria
- Have a specific genetic mutation known as BRAF V600E.
- Have certain genetic markers (dMMR+/MSI-H).
- Have only progressed after one type of chemotherapy treatment for advanced cancer.
- Have received any cancer treatment, including chemotherapy, radiation, or experimental drugs, within 28 days before starting ABBV-400.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group, PA /ID# 259424 | 72762 | Springdale | Arkansas |
| City of Hope National Medical Center /ID# 257576 | 91010 | Duarte | California |
| Yale School of Medicine /ID# 257494 | 06519 | New Haven | Connecticut |
| Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 260563 | 60611-2927 | Chicago | Illinois |
| Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601 | 46804 | Fort Wayne | Indiana |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 258789 | 46202-5116 | Indianapolis | Indiana |
| Community Health Network, Inc. /ID# 257078 | 46250-2042 | Indianapolis | Indiana |
| Comprehensive Cancer Centers of Nevada /ID# 257642 | 89052 | Henderson | Louisiana |
| Duke Cancer Center /ID# 257236 | 27710-3000 | Durham | North Carolina |
| Medical University of South Carolina /ID# 258486 | 29425 | Charleston | South Carolina |
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