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
← catalyst calendarNCT06107413 · readout ≤ 134 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
280estimated
Sites
64
Countries
Belgium, Germany, Israel +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-12 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Unresectable Metastatic Colorectal Cancer
Interventions
- Drug: ABBV-400
- Drug: Bevacizumab
- Drug: Folinic Acid
- Drug: Fluorouracil
- Drug: Irinotecan
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants with Objective Response
measured Up to 24 Weeks
Progression Free Survival (PFS)
measured Up to 11 Months
Number of Participants with Adverse Events (AEs)
measured Up to 3 Years
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