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Monoclonal Antibodies

ABBV-400 + Chemotherapy for Colorectal Cancer

Phase 2

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, ABBV-400, combined with three existing drugs to treat advanced colorectal cancer in adults. It aims to find the best dose that controls cancer growth and minimizes side effects. The study involves regular hospital visits and various medical tests.

Who is the study for?

Adults with confirmed unresectable metastatic colorectal cancer that can be measured by certain medical criteria. Participants must have been treated before and are able to attend regular study visits at a participating institution.

What is being tested?

The trial is testing ABBV-400, an experimental drug, in combination with Fluorouracil, Folinic Acid, and Bevacizumab for treating colorectal cancer. It involves different doses of ABBV-400 and compares it to the standard chemotherapy regimen in about 206 patients worldwide over approximately 3 years.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, increased risk of infection, bleeding complications from Bevacizumab use; specific side effects related to ABBV-400 will be monitored due to its investigational nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My colorectal cancer cannot be removed by surgery and has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Objective Response

Progression Free Survival (PFS)

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Percentage of Participants Achieving Best Overall Response (BOR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: FFB+Irinotecan (Standard of Care [SOC])Experimental Treatment4 Interventions

Participants will receive SOC during the 3 year study duration.

Group II: ABBV-400+Fluorouracil, Folinic Acid, and Bevacizumab (FFB) AExperimental Treatment4 Interventions

Participants will receive escalating ABBV-400 in combination with FFB on dose schedule A as part of the safety lead in, during the 3 year study duration.

Group III: ABBV-400+FFB B LowExperimental Treatment4 Interventions

Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule B as part of the dose optimization , during the 3 year study duration.

Group IV: ABBV-400+FFB B HighExperimental Treatment4 Interventions

Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule B as part of the dose optimization, during the 3 year study duration.

Group V: ABBV-400+FFB BExperimental Treatment4 Interventions

Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.

Group VI: ABBV-400+FFB A LowExperimental Treatment4 Interventions

Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.

Group VII: ABBV-400+FFB A HighExperimental Treatment4 Interventions

Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

2014

Completed Phase 3

~11700

Bevacizumab

2013

Completed Phase 4

~5540