Trial Title:
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
Condition:
Unresectable Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Folic Acid
Bevacizumab
Fluorouracil
Irinotecan
Levoleucovorin
Conditions: Keywords:
Unresectable Metastatic Colorectal Cancer
ABBV-400
Fluorouracil
Folinic Acid
Bevacizumab
Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-400
Description:
Intravenous (IV) Infusion
Arm group label:
ABBV-400+FFB A High
Arm group label:
ABBV-400+FFB A Low
Arm group label:
ABBV-400+FFB B
Arm group label:
ABBV-400+FFB B High
Arm group label:
ABBV-400+FFB B Low
Arm group label:
ABBV-400+Fluorouracil, Folinic Acid, and Bevacizumab (FFB) A
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
IV Infusion
Arm group label:
ABBV-400+FFB A High
Arm group label:
ABBV-400+FFB A Low
Arm group label:
ABBV-400+FFB B
Arm group label:
ABBV-400+FFB B High
Arm group label:
ABBV-400+FFB B Low
Arm group label:
ABBV-400+Fluorouracil, Folinic Acid, and Bevacizumab (FFB) A
Arm group label:
FFB+Irinotecan (Standard of Care [SOC])
Intervention type:
Drug
Intervention name:
Folinic Acid
Description:
IV Infusion
Arm group label:
ABBV-400+FFB A High
Arm group label:
ABBV-400+FFB A Low
Arm group label:
ABBV-400+FFB B
Arm group label:
ABBV-400+FFB B High
Arm group label:
ABBV-400+FFB B Low
Arm group label:
ABBV-400+Fluorouracil, Folinic Acid, and Bevacizumab (FFB) A
Arm group label:
FFB+Irinotecan (Standard of Care [SOC])
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
IV Infusion
Arm group label:
ABBV-400+FFB A High
Arm group label:
ABBV-400+FFB A Low
Arm group label:
ABBV-400+FFB B
Arm group label:
ABBV-400+FFB B High
Arm group label:
ABBV-400+FFB B Low
Arm group label:
ABBV-400+Fluorouracil, Folinic Acid, and Bevacizumab (FFB) A
Arm group label:
FFB+Irinotecan (Standard of Care [SOC])
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
IV Infusion
Arm group label:
FFB+Irinotecan (Standard of Care [SOC])
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.
Criteria for eligibility:
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:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology Group, PA /ID# 259424
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope National Medical Center /ID# 257576
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern University Robert H. Lurie Comprehensive Cancer Center /ID# 260563
Address:
City:
Chicago
Zip:
60611-2927
Country:
United States
Status:
Recruiting
Facility:
Name:
Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Facility:
Name:
Community Health Network, Inc. /ID# 257078
Address:
City:
Indianapolis
Zip:
46250-2042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
317-621-4300
Facility:
Name:
Duke Cancer Center /ID# 257236
Address:
City:
Durham
Zip:
27710-3000
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
919-668-1861
Facility:
Name:
Medical University of South Carolina /ID# 258486
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center /ID# 258713
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Millennium Research and Clinical Development /ID# 257780
Address:
City:
Houston
Zip:
77090-3063
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
281-440-5006
Facility:
Name:
Virginia Cancer Specialists - Fairfax /ID# 257261
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center /ID# 257090
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah /ID# 257088
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
Aichi Cancer Center Hospital /ID# 257286
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East /ID# 257282
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyoto University Hospital /ID# 257287
Address:
City:
Kyoto-shi
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital /ID# 257284
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital /ID# 257493
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Yonsei University Health System Severance Hospital /ID# 257492
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital /ID# 257639
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hosp /ID# 257636
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Start date:
November 12, 2023
Completion date:
October 1, 2026
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06107413
https://www.abbvieclinicaltrials.com/study/?id=M24-311
