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
NCT ID: NCT06107413
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
280 participants
INTERVENTIONAL
2023-11-12
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Stage 1: ABBV-400+FFB A
Participants 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.
ABBV-400
Intravenous (IV) Infusion
Bevacizumab
IV Infusion
Folinic Acid
IV Infusion
Fluorouracil
IV Infusion
Stage 1: ABBV-400+FFB B
Participants 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.
ABBV-400
Intravenous (IV) Infusion
Bevacizumab
IV Infusion
Folinic Acid
IV Infusion
Fluorouracil
IV Infusion
Stage 2: ABBV-400+FFB A Low
Participants 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.
ABBV-400
Intravenous (IV) Infusion
Bevacizumab
IV Infusion
Folinic Acid
IV Infusion
Fluorouracil
IV Infusion
Stage 2: ABBV-400+FFB A High
Participants 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.
ABBV-400
Intravenous (IV) Infusion
Bevacizumab
IV Infusion
Folinic Acid
IV Infusion
Fluorouracil
IV Infusion
Stage 2: FFB+Irinotecan (Standard of Care [SOC])
Participants will receive SOC during the 3 year study duration.
Bevacizumab
IV Infusion
Folinic Acid
IV Infusion
Fluorouracil
IV Infusion
Irinotecan
IV Infusion
Stage 3: ABBV-400+FFB B Low
Participants 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.
ABBV-400
Intravenous (IV) Infusion
Bevacizumab
IV Infusion
Folinic Acid
IV Infusion
Fluorouracil
IV Infusion
Stage 3: ABBV-400+Bevacizumab C High
Participants 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.
ABBV-400
Intravenous (IV) Infusion
Bevacizumab
IV Infusion
Interventions
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ABBV-400
Intravenous (IV) Infusion
Bevacizumab
IV Infusion
Folinic Acid
IV Infusion
Fluorouracil
IV Infusion
Irinotecan
IV Infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Mayo Clinic Arizona /ID# 262610
Phoenix, Arizona, United States
Highlands Oncology Group, PA /ID# 259424
Springdale, Arkansas, United States
City of Hope National Medical Center /ID# 257576
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365
Irvine, California, United States
Yale School of Medicine /ID# 257494
New Haven, Connecticut, United States
Mayo Clinic Hospital Jacksonville /ID# 262609
Jacksonville, Florida, United States
University of Illinois Hospital and Health Sciences System /ID# 257300
Chicago, Illinois, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563
Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center /ID# 258789
Indianapolis, Indiana, United States
Community Health Network, Inc. /ID# 257078
Indianapolis, Indiana, United States
Comprehensive Cancer Centers of Nevada /ID# 257642
Henderson, Louisiana, United States
Mayo Clinic - Rochester /ID# 257301
Rochester, Minnesota, United States
Atrium Health Levine Cancer Institute /ID# 258840
Charlotte, North Carolina, United States
Duke Cancer Institute /ID# 257236
Durham, North Carolina, United States
Oregon Health & Science University, Knight Cancer Institute- /ID# 259190
Portland, Oregon, United States
Medical University of South Carolina /ID# 258486
Charleston, South Carolina, United States
Avera Cancer Institute /ID# 257949
Sioux Falls, South Dakota, United States
MD Anderson Cancer Center /ID# 258713
Houston, Texas, United States
Texas Oncology PA /ID# 257780
Houston, Texas, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448
Fairfax, Virginia, United States
Virginia Cancer Specialists - Fairfax /ID# 257261
Fairfax, Virginia, United States
Imelda Ziekenhuis /ID# 257082
Bonheiden, Antwerpen, Belgium
Universitair Ziekenhuis Antwerpen /ID# 257080
Edegem, Antwerpen, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 257081
Brussels, Brussels Capital, Belgium
UZ Gent /ID# 257083
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 257079
Leuven, Vlaams-Brabant, Belgium
AZ-Delta /ID# 257084
Roeselare, West-Vlaanderen, Belgium
Institut Jules Bordet /ID# 257625
Anderlecht, , Belgium
Universitatsklinikum Mannheim /ID# 257781
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen /ID# 258780
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 257783
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787
Dresden, Saxony, Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 257785
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 257782
Hamburg, , Germany
Meir Medical Center /ID# 257089
Kfar Saba, Central District, Israel
Shaare Zedek Medical Center /ID# 259253
Jerusalem, Jerusalem, Israel
Hadassah /ID# 257088
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 257312
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 257090
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 257344
Haifa, , Israel
Assuta Medical Center /ID# 267581
Tel Aviv, , Israel
Aichi Cancer Center Hospital /ID# 257286
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 257282
Kashiwa-shi, Chiba, Japan
Kyoto University Hospital /ID# 257287
Kyoto, Kyoto, Japan
Shizuoka Cancer Center /ID# 257288
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 257284
Chuo-ku, Tokyo, Japan
Chonnam National University Hwasun Hospital /ID# 258366
Hwasun-gun, Jeonranamdo, South Korea
Seoul National University Hospital /ID# 257493
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 257845
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 257571
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 257492
Seoul, , South Korea
Hospital Universitario Vall de Hebron /ID# 257383
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 257387
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 257384
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 258549
Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 257385
Valencia, , Spain
Hospital Universitario Miguel Servet /ID# 257388
Zaragoza, , Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 257675
Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 257639
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital /ID# 257638
Tainan, , Taiwan
Taipei Veterans General Hosp /ID# 257636
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 257640
Taoyuan, , Taiwan
Countries
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Related Links
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Other Identifiers
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2023-505110-14
Identifier Type: OTHER
Identifier Source: secondary_id
M24-311
Identifier Type: -
Identifier Source: org_study_id
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