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NCT06107413 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Unresectable Metastatic Colorectal Cancer, sponsored by AbbVie.
- Active
- Registry status
- Phase 2
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT06107413 is a Phase 2 study of Unresectable Metastatic Colorectal Cancer that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 280 participants, above the 58-participant average among 3 other Unresectable Metastatic Colorectal Cancer trials with a reported enrollment target (383% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT06107413, a Phase 2 study of Unresectable Metastatic Colorectal Cancer, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2023-11-12 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 58-participant average among 3 other Unresectable Metastatic Colorectal Cancer trials with a reported enrollment target (383% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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.
NCT06107413 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Indiana, California, Illinois.
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.
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).
Who is sponsoring clinical trial NCT06107413?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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