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Assessing a new treatment for advanced colorectal cancer

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

Phase 2 Interventional AbbVie · NCT06107413

This study is testing a new drug called ABBV-400 combined with standard treatments to see if it can help adults with advanced colorectal cancer that can't be surgically removed.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, Bevacizumab
Locations63 sites (Phoenix, Arizona and 62 other locations)
Trial IDNCT06107413 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of ABBV-400, an investigational drug, when combined with standard treatments including Fluorouracil, Folinic Acid, and Bevacizumab in adults with unresectable metastatic colorectal cancer. Participants will be assigned to different treatment groups receiving varying doses of ABBV-400 alongside these established therapies. The study aims to monitor adverse events and changes in disease activity to determine the optimal dosing and treatment schedule. This phase 2 trial will help refine treatment strategies for patients who have not responded to initial therapies.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable metastatic colorectal cancer who have progressed after one prior systemic treatment.

Not a fit: Patients with specific genetic mutations like BRAF V600E or those who have received recent anticancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar combinations of therapies, but the specific use of ABBV-400 in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Phoenix, Arizona and 62 other locations

+13 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Unresectable Metastatic Colorectal CancerABBV-400FluorouracilFolinic AcidBevacizumabCancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.