Loading clinical trials...
Loading clinical trials...
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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 New Haven Hospital /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 Memorial Hospital /ID# 268610
Chicago, Illinois, United States
Hope And Healing Cancer Services /ID# 268541
Hinsdale, Illinois, United States
Start Date
November 8, 2024
Primary Completion Date
October 1, 2028
Completion Date
October 1, 2028
Last Updated
August 26, 2025
460
ESTIMATED participants
Telisotuzumab Adizutecan
DRUG
Trifluridine/Tipiracil
DRUG
Bevacizumab
DRUG
Lead Sponsor
AbbVie
NCT06625775
NCT04657068
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions