[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

JRCT ID: jRCT2031230442

Registered date:10/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: unresectable metastatic colorectal cancer
• Date of first enrollment: 06/12/2023
• Target sample size: 206
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

Primary Outcome

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.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude 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.

Related Information

• Primary Sponsor: Yamagishi Chika