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
Public ClinicalTrials.gov record NCT06107413. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study identification
- NCT ID
- NCT06107413
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 280 participants
Conditions and interventions
Conditions
Interventions
- ABBV-400 Drug
- Bevacizumab Drug
- Folinic Acid Drug
- Fluorouracil Drug
- Irinotecan Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 11, 2023
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Dec 11, 2025
2023 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona /ID# 262610 | Phoenix | Arizona | 85054 | — |
| Highlands Oncology Group, PA /ID# 259424 | Springdale | Arkansas | 72762 | — |
| City of Hope National Medical Center /ID# 257576 | Duarte | California | 91010 | — |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365 | Irvine | California | 92618 | — |
| Yale School of Medicine /ID# 257494 | New Haven | Connecticut | 06519 | — |
| Mayo Clinic Hospital Jacksonville /ID# 262609 | Jacksonville | Florida | 32224 | — |
| University of Illinois Hospital and Health Sciences System /ID# 257300 | Chicago | Illinois | 60607 | — |
| Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563 | Chicago | Illinois | 60611 | — |
| Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601 | Fort Wayne | Indiana | 46804 | — |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 258789 | Indianapolis | Indiana | 46202-5116 | — |
| Community Health Network, Inc. /ID# 257078 | Indianapolis | Indiana | 46250-2042 | — |
| Comprehensive Cancer Centers of Nevada /ID# 257642 | Henderson | Louisiana | 89052 | — |
| Mayo Clinic - Rochester /ID# 257301 | Rochester | Minnesota | 55905-0001 | — |
| Atrium Health Levine Cancer Institute /ID# 258840 | Charlotte | North Carolina | 28204 | — |
| Duke Cancer Institute /ID# 257236 | Durham | North Carolina | 27710 | — |
| Oregon Health & Science University, Knight Cancer Institute- /ID# 259190 | Portland | Oregon | 97239 | — |
| Medical University of South Carolina /ID# 258486 | Charleston | South Carolina | 29425 | — |
| Avera Cancer Institute /ID# 257949 | Sioux Falls | South Dakota | 57105 | — |
| MD Anderson Cancer Center /ID# 258713 | Houston | Texas | 77030 | — |
| Texas Oncology PA /ID# 257780 | Houston | Texas | 77090-3063 | — |
| Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448 | Fairfax | Virginia | 22031 | — |
| Virginia Cancer Specialists - Fairfax /ID# 257261 | Fairfax | Virginia | 22031 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06107413, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06107413 live on ClinicalTrials.gov.