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Unresectable Metastatic Colorectal CancerPhase 2NCT06107413

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 testing ABBV-400, Bevacizumab and Folinic Acid in people with Unresectable Metastatic Colorectal Cancer, run by AbbVie at 64 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABBV-400, Bevacizumab and Folinic Acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
64 sitesin 8 countries
Study dates
12 Nov 2023to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

64 sites in 8 countries.

64 sites in 8 countries

United States22 sites

  • Medical University of South Carolina /ID# 258486

    Charleston, South Carolina, 29425

  • Atrium Health Levine Cancer Institute /ID# 258840

    Charlotte, North Carolina, 28204

  • University of Illinois Hospital and Health Sciences System /ID# 257300

    Chicago, Illinois, 60607

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563

    Chicago, Illinois, 60611

  • City of Hope National Medical Center /ID# 257576

    Duarte, California, 91010

  • Duke Cancer Institute /ID# 257236

    Durham, North Carolina, 27710

  • Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448

    Fairfax, Virginia, 22031

  • Virginia Cancer Specialists - Fairfax /ID# 257261

    Fairfax, Virginia, 22031

  • Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601

    Fort Wayne, Indiana, 46804

  • Comprehensive Cancer Centers of Nevada /ID# 257642

    Henderson, Louisiana, 89052

  • MD Anderson Cancer Center /ID# 258713

    Houston, Texas, 77030

  • Texas Oncology PA /ID# 257780

    Houston, Texas, 77090-3063

  • Indiana University Melvin and Bren Simon Cancer Center /ID# 258789

    Indianapolis, Indiana, 46202-5116

  • Community Health Network, Inc. /ID# 257078

    Indianapolis, Indiana, 46250-2042

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365

    Irvine, California, 92618

  • Mayo Clinic Hospital Jacksonville /ID# 262609

    Jacksonville, Florida, 32224

  • Yale School of Medicine /ID# 257494

    New Haven, Connecticut, 06519

  • Mayo Clinic Arizona /ID# 262610

    Phoenix, Arizona, 85054

  • Oregon Health & Science University, Knight Cancer Institute- /ID# 259190

    Portland, Oregon, 97239

  • Mayo Clinic - Rochester /ID# 257301

    Rochester, Minnesota, 55905-0001

  • Avera Cancer Institute /ID# 257949

    Sioux Falls, South Dakota, 57105

  • Highlands Oncology Group, PA /ID# 259424

    Springdale, Arkansas, 72762

Other trials in United States

Belgium7 sites

  • Institut Jules Bordet /ID# 257625

    Anderlecht, 1070

  • Imelda Ziekenhuis /ID# 257082

    Bonheiden, Antwerpen, 2820

  • Cliniques Universitaires UCL Saint-Luc /ID# 257081

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Antwerpen /ID# 257080

    Edegem, Antwerpen, 2650

  • UZ Gent /ID# 257083

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven /ID# 257079

    Leuven, Vlaams-Brabant, 3000

  • AZ-Delta /ID# 257084

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Israel7 sites

  • Rambam Health Care Campus /ID# 257344

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 259253

    Jerusalem, Jerusalem, 91031

  • Hadassah /ID# 257088

    Jerusalem, Jerusalem, 91120

  • Meir Medical Center /ID# 257089

    Kfar Saba, Central District, 4428164

  • The Chaim Sheba Medical Center /ID# 257312

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 257090

    Tel Aviv, Tel Aviv, 6423906

  • Assuta Medical Center /ID# 267581

    Tel Aviv, 6789140

Other trials in Israel

Germany6 sites

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 257785

    Berlin, 13353

  • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 257787

    Dresden, Saxony, 01307

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 257782

    Hamburg, 20246

  • Universitatsklinikum Mannheim /ID# 257781

    Mannheim, Baden-Wurttemberg, 68167

  • Universitaetsklinikum Tuebingen /ID# 258780

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm /ID# 257783

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Spain6 sites

  • Hospital Universitario Vall de Hebron /ID# 257383

    Barcelona, 08035

  • Hospital General Universitario Gregorio Maranon /ID# 257387

    Madrid, 28007

  • Hospital Universitario 12 de Octubre /ID# 257384

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro /ID# 258549

    Madrid, 28050

  • Hospital Clinico Universitario de Valencia /ID# 257385

    Valencia, 46010

  • Hospital Universitario Miguel Servet /ID# 257388

    Zaragoza, 50009

Other trials in Spain

Taiwan6 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 257675

    Kaohsiung City, Kaohsiung, 833

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 257637

    Kaohsiung City, 807

  • National Cheng Kung University Hospital /ID# 257638

    Tainan, 704

  • Taipei Veterans General Hosp /ID# 257636

    Taipei, 11217

  • National Taiwan University Hospital /ID# 257639

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 257640

    Taoyuan City, 333

Other trials in Taiwan

Japan5 sites

  • National Cancer Center Hospital /ID# 257284

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 257282

    Kashiwa-shi, Chiba, 277-8577

  • Kyoto University Hospital /ID# 257287

    Kyoto, Kyoto, 606-8507

  • Aichi Cancer Center Hospital /ID# 257286

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center /ID# 257288

    Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

South Korea5 sites

  • Chonnam National University Hwasun Hospital /ID# 258366

    Hwasun-gun, Jeonranamdo, 58128

  • Seoul National University Hospital /ID# 257493

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 257845

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 257571

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 257492

    Seoul, 03722

Other trials in South Korea

About this study

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

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.

Read more

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.

Being tested
ABBV-400, Bevacizumab, Folinic Acid, Fluorouracil, Irinotecan
Keywords
Unresectable Metastatic Colorectal Cancer, ABBV-400, Fluorouracil, Folinic Acid, Bevacizumab, Cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06107413
Study groupRoleWhat they receive
Stage 1: ABBV-400+FFB AExperimentalParticipants 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.
Receives: Drug: ABBV-400; Drug: Bevacizumab; Drug: Folinic Acid; Drug: Fluorouracil
Stage 1: ABBV-400+FFB BExperimentalParticipants 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.
Receives: Drug: ABBV-400; Drug: Bevacizumab; Drug: Folinic Acid; Drug: Fluorouracil
Stage 2: ABBV-400+FFB A LowExperimentalParticipants 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.
Receives: Drug: ABBV-400; Drug: Bevacizumab; Drug: Folinic Acid; Drug: Fluorouracil
Stage 2: ABBV-400+FFB A HighExperimentalParticipants 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.
Receives: Drug: ABBV-400; Drug: Bevacizumab; Drug: Folinic Acid; Drug: Fluorouracil
Stage 2: FFB+Irinotecan (Standard of Care [SOC])ExperimentalParticipants will receive SOC during the 3 year study duration.
Receives: Drug: Bevacizumab; Drug: Folinic Acid; Drug: Fluorouracil; Drug: Irinotecan
Stage 3: ABBV-400+FFB B LowExperimentalParticipants 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.
Receives: Drug: ABBV-400; Drug: Bevacizumab; Drug: Folinic Acid; Drug: Fluorouracil
Stage 3: ABBV-400+Bevacizumab C HighExperimentalParticipants 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.
Receives: Drug: ABBV-400; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 Weeks

  2. 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.

    Measured: Up to 11 Months

  3. 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.

    Measured: Up to 3 Years

Secondary outcomes (3)

  1. Duration of Response (DOR)

    DOR is defined as The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first.

    Measured: Up to 7 Months

  2. Overall Survival (OS)

    OS is defined as the time from first dose of study drug to the event of death from any cause.

    Measured: Up to 3 Years

  3. Percentage of Participants Achieving Best Overall Response (BOR)

    BOR is defined as confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator.

    Measured: Up to 18 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start12 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06107413
Sponsor's protocol ID
M24-311
Other IDs
2023-505110-14, 2023
Status last verified
Dec 2025
First submitted
25 Oct 2023
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-400, Bevacizumab and Folinic Acid in people with Unresectable Metastatic Colorectal Cancer, run by AbbVie at 64 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Belgium, Israel, Germany, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Objective Response (time frame: Up to 24 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06107413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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