AbbVie
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.
Metastatic Colorectal Cancer
Telisotuzumab Adizutecan
Trifluridine/Tipiracil
Bevacizumab
PHASE3
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 460 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff |
| Actual Study Start Date : | 2024-11-08 |
| Estimated Primary Completion Date : | 2028-10 |
| Estimated Study Completion Date : | 2028-10 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
City of Hope National Medical Center /ID# 267875
Duarte, California, United States, 91010
RECRUITING
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
Irvine, California, United States, 92618
RECRUITING
USC Norris Comprehensive Cancer Center /ID# 268131
Los Angeles, California, United States, 90033
RECRUITING
Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
Golden, Colorado, United States, 80401
RECRUITING
Yale New Haven Hospital /ID# 269125
New Haven, Connecticut, United States, 06510
RECRUITING
AdventHealth Orlando /ID# 267970
Orlando, florida, United States, 32803
RECRUITING
Winship Cancer Institute of Emory University /ID# 266884
Atlanta, Georgia, United States, 30322
RECRUITING
St. Luke's Cancer Institute: Boise /ID# 268095
Boise, Idaho, United States, 83712
RECRUITING
Northwestern Memorial Hospital /ID# 268610
Chicago, Illinois, United States, 60611-2927
RECRUITING
Hope And Healing Cancer Services /ID# 268541
Hinsdale, Illinois, United States, 60521
RECRUITING
Springfield Clinic - First /ID# 268666
Springfield, Illinois, United States, 62702
RECRUITING
Community Cancer Center North /ID# 267965
Indianapolis, Indiana, United States, 46250
RECRUITING
Hattiesburg Clinic /ID# 267860
Hattiesburg, Mississippi, United States, 39401
RECRUITING
Washington University /ID# 267872
St Louis, Missouri, United States, 63110
RECRUITING
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185
Billings, Montana, United States, 59102
RECRUITING
Rutgers Cancer Institute of New Jersey /ID# 268056
New Brunswick, New Jersey, United States, 08901
RECRUITING
University of North Carolina Medical Center /ID# 266879
Chapel Hill, North Carolina, United States, 27514
RECRUITING
Duke University Medical Center /ID# 267966
Durham, North Carolina, United States, 27710
RECRUITING
Avera Cancer Institute - Sioux Falls /ID# 268074
Sioux Falls, South Dakota, United States, 57105
RECRUITING
West Cancer Center and Research Institute - Germantown /ID# 268619
Germantown, Tennessee, United States, 38138
RECRUITING
University of Texas - Southwestern Medical Center /ID# 268241
dallas, Texas, United States, 75235
RECRUITING
The University of Texas MD Anderson Cancer Center /ID# 268098
Houston, Texas, United States, 77030
COMPLETED
Millennium Research & Clinical Development /ID# 268400
Houston, Texas, United States, 77090
RECRUITING
University of Virginia /ID# 268108
Charlottesville, Virginia, United States, 22908
RECRUITING
Mater Hospital Brisbane /ID# 268360
South Brisbane, Queensland, Australia, 4101
RECRUITING
The Chaim Sheba Medical Center /ID# 267741
Ramat Gan, Tel Aviv, Israel, 5265601
RECRUITING
Tel Aviv Sourasky Medical Center /ID# 267578
Tel Aviv, Tel Aviv, Israel, 6423906
RECRUITING
Rambam Health Care Campus /ID# 267739
Haifa, Israel, 3525408
RECRUITING
Hadassah Medical Center-Hebrew University /ID# 267579
Jerusalem, Israel, 91120
RECRUITING
Rabin Medical Center /ID# 267740
Petah Pumpkin, Israel, 4941492
RECRUITING
Assuta Medical Center /ID# 267745
Tel Aviv, Israel, 6789140
RECRUITING
Aichi Cancer Center /ID# 268237
Nagoya, Aichi Prefecture, Japan, 464-8681
RECRUITING
National Cancer Center Hospital East /ID# 268236
Mr. Kashiwa, Chiba, Japan, 277-8577
RECRUITING
The University of Osaka Hospital /ID# 268743
Mr. Free, Osaka, Japan, 565-0871
RECRUITING
Saitama Prefectural Cancer Center /ID# 268706
Kitaadachi Army, Saitama, Japan, 362-0806
RECRUITING
National Cancer Center Hospital /ID# 268713
C goods-Ku, Tokyo, Japan, 104-0045
RECRUITING
Pan American Center for Oncology Trials /ID# 267888
Piedras River, Puerto Rico, 00935
RECRUITING
Seoul National University Bundang Hospital /ID# 268592
Seongnam-shi, Gyeonggi Do, South Korea, 13620
RECRUITING
Seoul National University Hospital /ID# 268719
Seoul, Seoul Teugbyeolsi, South Korea, 03080
RECRUITING
Yonsei University Health System Severance Hospital /ID# 268718
Seoul, Seoul Teugbyeolsi, South Korea, 03722
RECRUITING
Asan Medical Center /ID# 268717
Seoul, Seoul Teugbyeolsi, South Korea, 05505
RECRUITING
Samsung Medical Center /ID# 268720
Seoul, Seoul Teugbyeolsi, South Korea, 06351
RECRUITING
Kaohsiung Chang Gung Memorial Hospital /ID# 267638
City fast, Goversors, Taiwan, 833
RECRUITING
National Taiwan University Hospital /ID# 267627
Taipei City, Taipei, Taiwan, 100
RECRUITING
ClingoChristian hospital /ID# 270464
C jargon city, C jargon county, Taiwan, 50006
RECRUITING
Medical University Chung-Hospital.
City fast, Taiwan, 807
RECRUITING
China Medical University Hospital /ID# 267631
Taichung, Taiwan, 404
RECRUITING
Taichung Veterans General Hospital /ID# 270467
Taichung, Taiwan, 407
RECRUITING
National Cheng Kung University Hospital /ID# 270468
I think, Taiwan, 704
RECRUITING
Taipei Veterans General Hospital /ID# 267628
Taipei, Taiwan, 112
RECRUITING
Linkou Chang Gung Memorial Hospital /ID# 267637
tao yuan, Taiwan, 333