[M24-311]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

[M24-311]A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230442

Enrollment

206

Registered

2023-11-10

Start date

2024-01-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable metastatic colorectal cancer

Interventions

Drug: ABBV-400 iv Drug: Bevacizumab iv Drug: Folinic Acid iv Drug: Fluorouracil iv Drug: Irinotecan iv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC). Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion criteria

Exclusion criteria: Harbor the BRAF V600E mutation. dMMR+/MSI-H. Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy. 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.

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with Objective Response [Time Frame: Up to 24 Weeks] OR is defined as complete response (CR) and partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as assessed by the investigator. Progression Free Survival (PFS) [Time Frame: Up to 11 Months] 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.	—

Measure

Time frame

Percentage of Participants with Objective Response [Time Frame: Up to 24 Weeks] OR is defined as complete response (CR) and partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as assessed by the investigator. Progression Free Survival (PFS) [Time Frame: Up to 11 Months] 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.

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Secondary

Measure	Time frame
Duration of Response (DOR) [Time Frame: Up to 7 Months] 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. Overall Survival (OS) [Time Frame: Up to 3 Years] OS is defined as the time from first dose of study drug to the event of death from any cause. Percentage of Participants Achieving Best Overall Response (BOR) [Time Frame: Up to 18 Weeks] BOR is defined as confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator.	—

Measure

Time frame

Duration of Response (DOR) [Time Frame: Up to 7 Months] 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. Overall Survival (OS) [Time Frame: Up to 3 Years] OS is defined as the time from first dose of study drug to the event of death from any cause. Percentage of Participants Achieving Best Overall Response (BOR) [Time Frame: Up to 18 Weeks] BOR is defined as confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator.

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Countries

Japan, United States

Contacts

Public ContactMedical Information

AbbVie. G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026