Actively Recruiting
A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer
Led by AbbVie · Updated on 2025-08-26
460
Participants Needed
51
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events disease activity when comparing intravenously (IV) infused telisotuzumab adizutecan to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms as part of 2 stages. Each treatment arm in stage 1 receives a different dose of telisotuzumab adizutecan. Each treatment arm in stage 2 receives the optimal dose of telisotuzumab adizutecan or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study in approximately 160 sites in 15-20 countries. In stage 1, participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. In stage 2, participants will receive the optimal dose of IV infused telisotuzumab adizutecan or the standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. The total study duration will be approximately 4 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.
CONDITIONS
Official Title
A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy of at least 12 weeks as assessed by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during screening
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
You will not qualify if you...
- Prior treatment with systemic regimens containing c-MET targeting antibodies, bispecifics, or antibody drug conjugates
- History of allergic reactions or hypersensitivity to bevacizumab, trifluridine, tipiracil, or similar compounds
- Active infection as specified in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
City of Hope National Medical Center /ID# 267875
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
Irvine, California, United States, 92618
Actively Recruiting
3
USC Norris Comprehensive Cancer Center /ID# 268131
Los Angeles, California, United States, 90033
Actively Recruiting
4
Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
Golden, Colorado, United States, 80401
Actively Recruiting
5
Yale New Haven Hospital /ID# 269125
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
AdventHealth Orlando /ID# 267970
Orlando, Florida, United States, 32803
Actively Recruiting
7
Winship Cancer Institute of Emory University /ID# 266884
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
St. Luke's Cancer Institute: Boise /ID# 268095
Boise, Idaho, United States, 83712
Actively Recruiting
9
Northwestern Memorial Hospital /ID# 268610
Chicago, Illinois, United States, 60611-2927
Actively Recruiting
10
Hope And Healing Cancer Services /ID# 268541
Hinsdale, Illinois, United States, 60521
Actively Recruiting
11
Springfield Clinic - First /ID# 268666
Springfield, Illinois, United States, 62702
Actively Recruiting
12
Community Cancer Center North /ID# 267965
Indianapolis, Indiana, United States, 46250
Actively Recruiting
13
Hattiesburg Clinic /ID# 267860
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
14
Washington University /ID# 267872
St Louis, Missouri, United States, 63110
Actively Recruiting
15
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185
Billings, Montana, United States, 59102
Actively Recruiting
16
Rutgers Cancer Institute of New Jersey /ID# 268056
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
17
University of North Carolina Medical Center /ID# 266879
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
18
Duke University Medical Center /ID# 267966
Durham, North Carolina, United States, 27710
Actively Recruiting
19
Avera Cancer Institute - Sioux Falls /ID# 268074
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
20
West Cancer Center and Research Institute - Germantown /ID# 268619
Germantown, Tennessee, United States, 38138
Actively Recruiting
21
University of Texas - Southwestern Medical Center /ID# 268241
Dallas, Texas, United States, 75235
Actively Recruiting
22
The University of Texas MD Anderson Cancer Center /ID# 268098
Houston, Texas, United States, 77030
Actively Recruiting
23
Millennium Research & Clinical Development /ID# 268400
Houston, Texas, United States, 77090
Completed
24
University of Virginia /ID# 268108
Charlottesville, Virginia, United States, 22908
Actively Recruiting
25
Mater Hospital Brisbane /ID# 268360
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
26
The Chaim Sheba Medical Center /ID# 267741
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
27
Tel Aviv Sourasky Medical Center /ID# 267578
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
28
Rambam Health Care Campus /ID# 267739
Haifa, Israel, 3525408
Actively Recruiting
29
Hadassah Medical Center-Hebrew University /ID# 267579
Jerusalem, Israel, 91120
Actively Recruiting
30
Rabin Medical Center /ID# 267740
Petah Tikva, Israel, 4941492
Actively Recruiting
31
Assuta Medical Center /ID# 267745
Tel Aviv, Israel, 6789140
Actively Recruiting
32
Aichi Cancer Center /ID# 268237
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
33
National Cancer Center Hospital East /ID# 268236
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
34
The University of Osaka Hospital /ID# 268743
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
35
Saitama Prefectural Cancer Center /ID# 268706
Kitaadachi-gun, Saitama, Japan, 362-0806
Actively Recruiting
36
National Cancer Center Hospital /ID# 268713
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
37
Pan American Center for Oncology Trials /ID# 267888
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
38
Seoul National University Bundang Hospital /ID# 268592
Seongnam-si, Gyeonggido, South Korea, 13620
Actively Recruiting
39
Seoul National University Hospital /ID# 268719
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
40
Yonsei University Health System Severance Hospital /ID# 268718
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
41
Asan Medical Center /ID# 268717
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
42
Samsung Medical Center /ID# 268720
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
43
Kaohsiung Chang Gung Memorial Hospital /ID# 267638
Kaohsiung City, Kaohsiung, Taiwan, 833
Actively Recruiting
44
National Taiwan University Hospital /ID# 267627
Taipei City, Taipei, Taiwan, 100
Actively Recruiting
45
Changhua Christian Hospital /ID# 270464
Changhua City, Changhua County, Taiwan, 50006
Actively Recruiting
46
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635
Kaohsiung City, Taiwan, 807
Actively Recruiting
47
China Medical University Hospital /ID# 267631
Taichung, Taiwan, 404
Actively Recruiting
48
Taichung Veterans General Hospital /ID# 270467
Taichung, Taiwan, 407
Actively Recruiting
49
National Cheng Kung University Hospital /ID# 270468
Tainan, Taiwan, 704
Actively Recruiting
50
Taipei Veterans General Hospital /ID# 267628
Taipei, Taiwan, 112
Actively Recruiting
51
Linkou Chang Gung Memorial Hospital /ID# 267637
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here