Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab
Sponsor: AbbVie
ClinicalTrials ID:NCT06107413
This study evaluates adverse events and disease activity changes in adults with unresectable metastatic colorectal cancer. Participants must have confirmed mCRC and measurable disease per RECIST v1.1. Interventions include IV infusions of ABBV-400, Bevacizumab, Folinic Acid, Fluorouracil, and Irinotecan. The trial involves dose escalation and optimization phases.
Patient Parameters
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Program Overview
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.
ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab (FFB) in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care [SOC]) [dose optimization] on its own. Approximately 206 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide.
In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with FFB at low or high doses determined in the safety lead in. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. The study will run for a duration of approximately 3 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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria
- Harbor the BRAF V600E mutation.
- dMMR+/MSI-H.
- Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
- Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of 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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