← Back to Search

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

Study Summary

This trial will assess the adverse events and change in disease activity when ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab is given to adult participants with unresectable metastatic colorectal cancer.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with Objective Response

Progression Free Survival (PFS)

Secondary outcome measures

Duration of Response (DOR)

Overall Survival (OS)

Percentage of Participants Achieving Best Overall Response (BOR)

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

Folinic Acid

2015

Completed Phase 3

~4380

Bevacizumab

2013

Completed Phase 4

~5280

Fluorouracil

2014

Completed Phase 3

~11540

Irinotecan

2017

Completed Phase 4

~2680

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

958 Previous Clinical Trials

502,184 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

397 Previous Clinical Trials

146,903 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can be included in this experiment?

"Affirmative. According to the clinicaltrials.gov website, this medical experiment is presently recruiting patients; it was originally posted on November 12th 2023 and has been recently updated on November 21st of that same year. The trial needs a total of 206 participants from 3 different locations."

Answered by AI

Is this trial enrolling participants presently?

"Affirmative. Clinicaltrials.gov states that this experiment began recruitment on November 12th 2023 and was recently updated on the 21st of November in the same year. 206 volunteers are needed from 3 distinct locations to complete the trial."

Answered by AI