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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

NCT06614192 · AbbVie
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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
About this study
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.
Eligibility criteria
Inclusion Criteria: * Life expectancy \>= 12 weeks per investigator assessment. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Exclusion Criteria: * Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate \[ADC\]). * History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. * Active infection as noted in the protocol.
Study design
Enrollment target: 460 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-11-08
Estimated completion: 2028-10
Last updated: 2025-08-26
Interventions
Drug: Telisotuzumab AdizutecanDrug: Trifluridine/TipiracilDrug: Bevacizumab
Primary outcomes
  • Stage 1: Percentage of Participants with Adverse Events (AE)s (Up to a Maximum of 4 Years)
  • Stage 1: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator (Up to a Maximum of 4 Years)
  • Stage 1: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator (Up to a Maximum of 4 Years)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (51)
City of Hope National Medical Center /ID# 267875Recruiting
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655Recruiting
Irvine, California, United States
USC Norris Comprehensive Cancer Center /ID# 268131Recruiting
Los Angeles, California, United States
Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175Recruiting
Golden, Colorado, United States
Yale New Haven Hospital /ID# 269125Recruiting
New Haven, Connecticut, United States
AdventHealth Orlando /ID# 267970Recruiting
Orlando, Florida, United States
Winship Cancer Institute of Emory University /ID# 266884Recruiting
Atlanta, Georgia, United States
St. Luke's Cancer Institute: Boise /ID# 268095Recruiting
Boise, Idaho, United States
Northwestern Memorial Hospital /ID# 268610Recruiting
Chicago, Illinois, United States
Hope And Healing Cancer Services /ID# 268541Recruiting
Hinsdale, Illinois, United States
Springfield Clinic - First /ID# 268666Recruiting
Springfield, Illinois, United States
Community Cancer Center North /ID# 267965Recruiting
Indianapolis, Indiana, United States
Hattiesburg Clinic /ID# 267860Recruiting
Hattiesburg, Mississippi, United States
Washington University /ID# 267872Recruiting
St Louis, Missouri, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185Recruiting
Billings, Montana, United States
Rutgers Cancer Institute of New Jersey /ID# 268056Recruiting
New Brunswick, New Jersey, United States
University of North Carolina Medical Center /ID# 266879Recruiting
Chapel Hill, North Carolina, United States
Duke University Medical Center /ID# 267966Recruiting
Durham, North Carolina, United States
Avera Cancer Institute - Sioux Falls /ID# 268074Recruiting
Sioux Falls, South Dakota, United States
West Cancer Center and Research Institute - Germantown /ID# 268619Recruiting
Germantown, Tennessee, United States
University of Texas - Southwestern Medical Center /ID# 268241Recruiting
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center /ID# 268098Recruiting
Houston, Texas, United States
Millennium Research & Clinical Development /ID# 268400Completed
Houston, Texas, United States
University of Virginia /ID# 268108Recruiting
Charlottesville, Virginia, United States
Mater Hospital Brisbane /ID# 268360Recruiting
South Brisbane, Queensland, Australia
The Chaim Sheba Medical Center /ID# 267741Recruiting
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 267578Recruiting
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 267739Recruiting
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 267579Recruiting
Jerusalem, Israel
Rabin Medical Center /ID# 267740Recruiting
Petah Tikva, Israel
Assuta Medical Center /ID# 267745Recruiting
Tel Aviv, Israel
Aichi Cancer Center /ID# 268237Recruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 268236Recruiting
Kashiwa-shi, Chiba, Japan
The University of Osaka Hospital /ID# 268743Recruiting
Suita-shi, Osaka, Japan
Saitama Prefectural Cancer Center /ID# 268706Recruiting
Kitaadachi-gun, Saitama, Japan
National Cancer Center Hospital /ID# 268713Recruiting
Chuo-Ku, Tokyo, Japan
Pan American Center for Oncology Trials /ID# 267888Recruiting
Rio Piedras, Puerto Rico
Seoul National University Bundang Hospital /ID# 268592Recruiting
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 268719Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 268718Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 268717Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 268720Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Kaohsiung Chang Gung Memorial Hospital /ID# 267638Recruiting
Kaohsiung City, Kaohsiung, Taiwan
National Taiwan University Hospital /ID# 267627Recruiting
Taipei City, Taipei, Taiwan
Changhua Christian Hospital /ID# 270464Recruiting
Changhua City, Changhua County, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635Recruiting
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 267631Recruiting
Taichung, Taiwan
Taichung Veterans General Hospital /ID# 270467Recruiting
Taichung, Taiwan
National Cheng Kung University Hospital /ID# 270468Recruiting
Tainan, Taiwan
Taipei Veterans General Hospital /ID# 267628Recruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 267637Recruiting
Taoyuan, Taiwan
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 · TrialPath