A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Fluorouracil, Folinic Acid, and Bevacizumab and to Evaluate Safety and Efficacy of ABBV-400 in Combination with Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505110-14-00

Acronym

M24-311

Enrollment

Registered

2024-08-02

Start date

2024-12-02

Completion date

Unknown

Last updated

2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

Objective Response as assessed by the investigator, Progression Free Survival (PFS) as assessed by the investigator

Detailed description

Duration of Response (DOR) as assessed by the investigator, Overall Survival (OS), Best Overall Response (BOR) as assessed by the investigator

Interventions

DRUGIRINOTECAN

DRUGBEVACIZUMAB

DRUGFLUOROURACIL

DRUGABBV-400

DRUGFOLINIC ACID

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response as assessed by the investigator, Progression Free Survival (PFS) as assessed by the investigator	—

Secondary

Measure	Time frame
Duration of Response (DOR) as assessed by the investigator, Overall Survival (OS), Best Overall Response (BOR) as assessed by the investigator	—

Countries

Belgium, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026