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A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer
Sponsor: AbbVie
Summary
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 and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan 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 and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries. Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. 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.
Official title: AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2024-11-08
Completion Date
2027-08
Last Updated
2026-05-28
Healthy Volunteers
No
Conditions
Interventions
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Locations (51)
City of Hope National Medical Center /ID# 267875
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
Irvine, California, United States
USC Norris Comprehensive Cancer Center /ID# 268131
Los Angeles, California, United States
Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
Golden, Colorado, United States
Yale University School of Medicine /ID# 269125
New Haven, Connecticut, United States
AdventHealth Orlando /ID# 267970
Orlando, Florida, United States
Winship Cancer Institute of Emory University /ID# 266884
Atlanta, Georgia, United States
St. Luke's Cancer Institute: Boise /ID# 268095
Boise, Idaho, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610
Chicago, Illinois, United States
Hope And Healing Cancer Services /ID# 268541
Hinsdale, Illinois, United States
Springfield Clinic - First /ID# 268666
Springfield, Illinois, United States
Community Cancer Center North /ID# 267965
Indianapolis, Indiana, United States
Hattiesburg Clinic /ID# 267860
Hattiesburg, Mississippi, United States
Washington University /ID# 267872
St Louis, Missouri, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185
Billings, Montana, United States
Rutgers Cancer Institute of New Jersey /ID# 268056
New Brunswick, New Jersey, United States
University of North Carolina Medical Center /ID# 266879
Chapel Hill, North Carolina, United States
Duke University Medical Center /ID# 267966
Durham, North Carolina, United States
Avera Cancer Institute - Sioux Falls /ID# 268074
Sioux Falls, South Dakota, United States
West Cancer Center and Research Institute - Germantown /ID# 268619
Germantown, Tennessee, United States
University of Texas - Southwestern Medical Center /ID# 268241
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center /ID# 268098
Houston, Texas, United States
Millennium Physicians /ID# 268400
Houston, Texas, United States
University of Virginia /ID# 268108
Charlottesville, Virginia, United States
Mater Hospital Brisbane /ID# 268360
South Brisbane, Queensland, Australia
Rabin Medical Center. /ID# 267740
Petah Tikva, Central District, Israel
The Chaim Sheba Medical Center /ID# 267741
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 267578
Tel Aviv, Tel Aviv, Israel
Assuta Medical Center - Tel Aviv /ID# 267745
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 267739
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 267579
Jerusalem, Israel
Aichi Cancer Center /ID# 268237
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 268236
Kashiwa-shi, Chiba, Japan
The University of Osaka Hospital /ID# 268743
Suita-shi, Osaka, Japan
Saitama Prefectural Cancer Center /ID# 268706
Kitaadachi-gun, Saitama, Japan
National Cancer Center Hospital /ID# 268713
Chuo-Ku, Tokyo, Japan
Pan American Center for Oncology Trials - Rio Piedras /ID# 267888
Rio Piedras, Puerto Rico
Seoul National University Bundang Hospital /ID# 268592
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 268719
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 268718
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 268717
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 268720
Seoul, Seoul Teugbyeolsi, South Korea
Changhua Christian Hospital /ID# 270464
Changhua City, Changhua County, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital /ID# 267638
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 267631
Taichung, Taiwan
Taichung Veterans General Hospital /ID# 270467
Taichung, Taiwan
National Cheng Kung University Hospital /ID# 270468
Tainan, Taiwan
National Taiwan University Hospital /ID# 267627
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 267628
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 267637
Taoyuan City, Taiwan