Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Unresectable Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 gi...
Eligibility Criteria
Inclusion
- Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
Exclusion
- Harbor the BRAF V600E mutation.
- dMMR+/MSI-H.
- 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.
Key Trial Info
Start Date :
November 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06107413
Start Date
November 12 2023
End Date
December 1 2026
Last Update
December 12 2025
Active Locations (64)
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1
Mayo Clinic Arizona /ID# 262610
Phoenix, Arizona, United States, 85054
2
Highlands Oncology Group, PA /ID# 259424
Springdale, Arkansas, United States, 72762
3
City of Hope National Medical Center /ID# 257576
Duarte, California, United States, 91010
4
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365
Irvine, California, United States, 92618