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An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months. 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.

• Life expectancy \>= 12 weeks per investigator assessment

Locations
Other Locations
Belgium
Algemeen Ziekenhuis klina /ID# 279331
NOT_YET_RECRUITING
Brasschaat
Japan
National Cancer Center Hospital East /ID# 279917
RECRUITING
Kashiwa-shi
Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708
RECRUITING
New Taipei City
Taipei Medical University Hospital /ID# 280607
RECRUITING
Taipei
Taipei Municipal Wan Fang Hospital /ID# 280285
RECRUITING
Taipei
Tri-Service General Hospital - Neihu Branch /ID# 279768
RECRUITING
Taipei
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2026-05-22
Estimated Completion Date: 2029-05
Participants
Target number of participants: 700
Treatments
Experimental: Ph 3: Telisotuzumab Adizutecan + Bevacizumab
Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
Experimental: Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab
Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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