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ACTIVE NOT RECRUITING Phase 2

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

NCT06107413 · View on ClinicalTrials.gov ↗

Study Summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer. ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab (FFB) is an approved drug for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with FFB in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care \[SOC\]) \[dose optimization\] on its own, ending with low or high doses of ABBV-400 in combination with FFB for continued dose optimization and expansion. Approximately 280 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide. In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with IV FFB at low or high doses determined in the safety lead in. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. During the dose optimization and expansion stage, participants will receive IV ABBV-400 in combination with IV FFB at low or high doses that have been determined from the previous stages. The study will run for a duration of approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participan

Interventions

  • DRUG Bevacizumab
  • DRUG Fluorouracil
  • DRUG Irinotecan
  • DRUG Folinic Acid
  • DRUG ABBV-400

Study Locations (20)

Indiana

  • Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601 — Fort Wayne
  • Indiana University Melvin and Bren Simon Cancer Center /ID# 258789 — Indianapolis
  • Community Health Network, Inc. /ID# 257078 — Indianapolis

California

  • City of Hope National Medical Center /ID# 257576 — Duarte
  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365 — Irvine

Illinois

  • University of Illinois Hospital and Health Sciences System /ID# 257300 — Chicago
  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563 — Chicago

North Carolina

  • Atrium Health Levine Cancer Institute /ID# 258840 — Charlotte
  • Duke Cancer Institute /ID# 257236 — Durham

Texas

  • MD Anderson Cancer Center /ID# 258713 — Houston
  • Texas Oncology PA /ID# 257780 — Houston

Arizona

  • Mayo Clinic Arizona /ID# 262610 — Phoenix

Arkansas

  • Highlands Oncology Group, PA /ID# 259424 — Springdale

Connecticut

  • Yale School of Medicine /ID# 257494 — New Haven

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2023-11-12
Est. Completion 2026-12
Phase Phase 2

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06107413

The ClinicalTrials.gov registry entry for NCT06107413 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Unresectable Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06107413 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Indiana, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06107413 about?

NCT06107413 is a clinical study titled "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". Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat u...

What is the current status of trial NCT06107413?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2023-11-12. Estimated completion is 2026-12.

What conditions does trial NCT06107413 study?

This clinical trial studies the following conditions: Unresectable Metastatic Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06107413?

The interventions under investigation include: Bevacizumab (DRUG), Fluorouracil (DRUG), Irinotecan (DRUG), Folinic Acid (DRUG), ABBV-400 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06107413?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06107413 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial