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, 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
2 other identifiers
interventional
280
8 countries
64
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2023
Typical duration for phase_2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2023
CompletedStudy Start
First participant enrolled
November 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 12, 2025
December 1, 2025
3.1 years
October 25, 2023
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants with Objective Response
OR is defined as complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as assessed by the investigator.
Up to 24 Weeks
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
Up to 11 Months
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to 3 Years
Secondary Outcomes (3)
Duration of Response (DOR)
Up to 7 Months
Overall Survival (OS)
Up to 3 Years
Percentage of Participants Achieving Best Overall Response (BOR)
Up to 18 Weeks
Study Arms (7)
Stage 1: ABBV-400+FFB A
EXPERIMENTALParticipants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB B
EXPERIMENTALParticipants 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.
Stage 2: ABBV-400+FFB A Low
EXPERIMENTALParticipants 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.
Stage 2: ABBV-400+FFB A High
EXPERIMENTALParticipants 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.
Stage 2: FFB+Irinotecan (Standard of Care [SOC])
EXPERIMENTALParticipants will receive SOC during the 3 year study duration.
Stage 3: ABBV-400+FFB B Low
EXPERIMENTALParticipants 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/expansion, during the 3 year study duration.
Stage 3: ABBV-400+Bevacizumab C High
EXPERIMENTALParticipants will receive ABBV-400 in combination with Bevacizumab at the high dose determined in the safety lead in on dose schedule C as part of the dose optimization/expansion, during the 3 year study duration.
Interventions
Intravenous (IV) Infusion
IV Infusion
IV Infusion
IV Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (64)
Mayo Clinic Arizona /ID# 262610
Phoenix, Arizona, 85054, United States
Highlands Oncology Group, PA /ID# 259424
Springdale, Arkansas, 72762, United States
City of Hope National Medical Center /ID# 257576
Duarte, California, 91010, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365
Irvine, California, 92618, United States
Yale School of Medicine /ID# 257494
New Haven, Connecticut, 06519, United States
Mayo Clinic Hospital Jacksonville /ID# 262609
Jacksonville, Florida, 32224, United States
University of Illinois Hospital and Health Sciences System /ID# 257300
Chicago, Illinois, 60607, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563
Chicago, Illinois, 60611, United States
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601
Fort Wayne, Indiana, 46804, United States
Indiana University Melvin and Bren Simon Cancer Center /ID# 258789
Indianapolis, Indiana, 46202-5116, United States
Community Health Network, Inc. /ID# 257078
Indianapolis, Indiana, 46250-2042, United States
Comprehensive Cancer Centers of Nevada /ID# 257642
Henderson, Louisiana, 89052, United States
Mayo Clinic - Rochester /ID# 257301
Rochester, Minnesota, 55905-0001, United States
Atrium Health Levine Cancer Institute /ID# 258840
Charlotte, North Carolina, 28204, United States
Duke Cancer Institute /ID# 257236
Durham, North Carolina, 27710, United States
Oregon Health & Science University, Knight Cancer Institute- /ID# 259190
Portland, Oregon, 97239, United States
Medical University of South Carolina /ID# 258486
Charleston, South Carolina, 29425, United States
Avera Cancer Institute /ID# 257949
Sioux Falls, South Dakota, 57105, United States
MD Anderson Cancer Center /ID# 258713
Houston, Texas, 77030, United States
Texas Oncology PA /ID# 257780
Houston, Texas, 77090-3063, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists - Fairfax /ID# 257261
Fairfax, Virginia, 22031, United States
Imelda Ziekenhuis /ID# 257082
Bonheiden, Antwerpen, 2820, Belgium
Universitair Ziekenhuis Antwerpen /ID# 257080
Edegem, Antwerpen, 2650, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 257081
Brussels, Brussels Capital, 1200, Belgium
UZ Gent /ID# 257083
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 257079
Leuven, Vlaams-Brabant, 3000, Belgium
AZ-Delta /ID# 257084
Roeselare, West-Vlaanderen, 8800, Belgium
Institut Jules Bordet /ID# 257625
Anderlecht, 1070, Belgium
Universitatsklinikum Mannheim /ID# 257781
Mannheim, Baden-Wurttemberg, 68167, Germany
Universitaetsklinikum Tuebingen /ID# 258780
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Ulm /ID# 257783
Ulm, Baden-Wurttemberg, 89081, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787
Dresden, Saxony, 01307, Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 257785
Berlin, 13353, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 257782
Hamburg, 20246, Germany
Meir Medical Center /ID# 257089
Kfar Saba, Central District, 4428164, Israel
Shaare Zedek Medical Center /ID# 259253
Jerusalem, Jerusalem, 91031, Israel
Hadassah /ID# 257088
Jerusalem, Jerusalem, 91120, Israel
The Chaim Sheba Medical Center /ID# 257312
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 257090
Tel Aviv, Tel Aviv, 6423906, Israel
Rambam Health Care Campus /ID# 257344
Haifa, 3109601, Israel
Assuta Medical Center /ID# 267581
Tel Aviv, 6789140, Israel
Aichi Cancer Center Hospital /ID# 257286
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East /ID# 257282
Kashiwa-shi, Chiba, 277-8577, Japan
Kyoto University Hospital /ID# 257287
Kyoto, Kyoto, 606-8507, Japan
Shizuoka Cancer Center /ID# 257288
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital /ID# 257284
Chuo-ku, Tokyo, 104-0045, Japan
Chonnam National University Hwasun Hospital /ID# 258366
Hwasun-gun, Jeonranamdo, 58128, South Korea
Seoul National University Hospital /ID# 257493
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center /ID# 257845
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 257571
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Yonsei University Health System Severance Hospital /ID# 257492
Seoul, 03722, South Korea
Hospital Universitario Vall de Hebron /ID# 257383
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Maranon /ID# 257387
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre /ID# 257384
Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro /ID# 258549
Madrid, 28050, Spain
Hospital Clinico Universitario de Valencia /ID# 257385
Valencia, 46010, Spain
Hospital Universitario Miguel Servet /ID# 257388
Zaragoza, 50009, Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 257675
Kaohsiung City, Kaohsiung, 833, Taiwan
National Taiwan University Hospital /ID# 257639
Taipei City, Taipei, 100, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637
Kaohsiung City, 807, Taiwan
National Cheng Kung University Hospital /ID# 257638
Tainan, 704, Taiwan
Taipei Veterans General Hosp /ID# 257636
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 257640
Taoyuan, 333, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2023
First Posted
October 30, 2023
Study Start
November 12, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 12, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.