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

Unresectable Metastatic Colorectal Cancer Clinical Trial

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 in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107413
• Other study ID #: M24-311
• Secondary ID: 2023-505110-14-0
• Status: Recruiting
• Phase: Phase 2
• Start date: November 12, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 metastatic colorectal cancer. ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved 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 fluorouracil, folinic acid, and bevacizumab (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. Approximately 206 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 FFB at low or high doses determined in the safety lead in on two different dosing schedules. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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 Conditions & MeSH terms

• Colorectal Neoplasms
• Unresectable Metastatic Colorectal Cancer

Intervention

Drug:
• ABBV-400
Intravenous (IV) Infusion
• Bevacizumab
IV Infusion
• Folinic Acid
IV Infusion
• Fluorouracil
IV Infusion
• Irinotecan
IV Infusion

Locations

Country	Name	City	State
Israel	Hadassah /ID# 257088	Jerusalem	Yerushalayim
Israel	Tel Aviv Sourasky Medical Center /ID# 257090	Tel Aviv	Tel-Aviv
Japan	National Cancer Center Hospital /ID# 257284	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East /ID# 257282	Kashiwa-shi	Chiba
Japan	Kyoto University Hospital /ID# 257287	Kyoto-shi	Kyoto
Japan	Aichi Cancer Center Hospital /ID# 257286	Nagoya-shi	Aichi
Korea, Republic of	Seoul National University Hospital /ID# 257493	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 257492	Seoul	Seoul Teugbyeolsi
Taiwan	Taipei Veterans General Hosp /ID# 257636	Taipei
Taiwan	National Taiwan University Hospital /ID# 257639	Taipei City
United States	Medical University of South Carolina /ID# 258486	Charleston	South Carolina
United States	Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 260563	Chicago	Illinois
United States	City of Hope National Medical Center /ID# 257576	Duarte	California
United States	Duke Cancer Center /ID# 257236	Durham	North Carolina
United States	Virginia Cancer Specialists - Fairfax /ID# 257261	Fairfax	Virginia
United States	Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601	Fort Wayne	Indiana
United States	Millennium Research and Clinical Development /ID# 257780	Houston	Texas
United States	Community Health Network, Inc. /ID# 257078	Indianapolis	Indiana
United States	Highlands Oncology Group, PA /ID# 259424	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Israel,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Objective Response	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.	Up to 24 Weeks
Primary	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
Secondary	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.	Up to 7 Months
Secondary	Overall Survival (OS)	OS is defined as the time from first dose of study drug to the event of death from any cause.	Up to 3 Years
Secondary	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.	Up to 18 Weeks

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