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

Status: Recruiting
Location: See all (51) 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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
City of Hope National Medical Center /ID# 267875
RECRUITING
Duarte
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
RECRUITING
Irvine
USC Norris Comprehensive Cancer Center /ID# 268131
RECRUITING
Los Angeles
Colorado
Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
RECRUITING
Golden
Connecticut
Yale New Haven Hospital /ID# 269125
RECRUITING
New Haven
Florida
AdventHealth Orlando /ID# 267970
RECRUITING
Orlando
Georgia
Winship Cancer Institute of Emory University /ID# 266884
RECRUITING
Atlanta
Idaho
St. Luke's Cancer Institute: Boise /ID# 268095
RECRUITING
Boise
Illinois
Northwestern Memorial Hospital /ID# 268610
RECRUITING
Chicago
Hope And Healing Cancer Services /ID# 268541
RECRUITING
Hinsdale
Springfield Clinic - First /ID# 268666
RECRUITING
Springfield
Indiana
Community Cancer Center North /ID# 267965
RECRUITING
Indianapolis
Missouri
Washington University /ID# 267872
RECRUITING
St Louis
Mississippi
Hattiesburg Clinic /ID# 267860
RECRUITING
Hattiesburg
Montana
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185
RECRUITING
Billings
North Carolina
University of North Carolina Medical Center /ID# 266879
RECRUITING
Chapel Hill
Duke University Medical Center /ID# 267966
RECRUITING
Durham
New Jersey
Rutgers Cancer Institute of New Jersey /ID# 268056
RECRUITING
New Brunswick
South Dakota
Avera Cancer Institute - Sioux Falls /ID# 268074
RECRUITING
Sioux Falls
Tennessee
West Cancer Center and Research Institute - Germantown /ID# 268619
RECRUITING
Germantown
Texas
University of Texas - Southwestern Medical Center /ID# 268241
RECRUITING
Dallas
Millennium Research & Clinical Development /ID# 268400
COMPLETED
Houston
The University of Texas MD Anderson Cancer Center /ID# 268098
RECRUITING
Houston
Virginia
University of Virginia /ID# 268108
RECRUITING
Charlottesville
Other Locations
Australia
Mater Hospital Brisbane /ID# 268360
RECRUITING
South Brisbane
Israel
Rambam Health Care Campus /ID# 267739
RECRUITING
Haifa
Hadassah Medical Center-Hebrew University /ID# 267579
RECRUITING
Jerusalem
Rabin Medical Center /ID# 267740
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 267741
RECRUITING
Ramat Gan
Assuta Medical Center /ID# 267745
RECRUITING
Tel Aviv
Tel Aviv Sourasky Medical Center /ID# 267578
RECRUITING
Tel Aviv
Japan
National Cancer Center Hospital /ID# 268713
RECRUITING
Chuo-ku
National Cancer Center Hospital East /ID# 268236
RECRUITING
Kashiwa-shi
Saitama Prefectural Cancer Center /ID# 268706
RECRUITING
Kitaadachi-gun
Aichi Cancer Center /ID# 268237
RECRUITING
Nagoya
The University of Osaka Hospital /ID# 268743
RECRUITING
Suita-shi
Puerto Rico
Pan American Center for Oncology Trials /ID# 267888
RECRUITING
Rio Piedras
Republic of Korea
Seoul National University Bundang Hospital /ID# 268592
RECRUITING
Seongnam-si
Asan Medical Center /ID# 268717
RECRUITING
Seoul
Samsung Medical Center /ID# 268720
RECRUITING
Seoul
Seoul National University Hospital /ID# 268719
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 268718
RECRUITING
Seoul
Taiwan
Changhua Christian Hospital /ID# 270464
RECRUITING
Changhua City, Changhua County
Kaohsiung Chang Gung Memorial Hospital /ID# 267638
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635
RECRUITING
Kaohsiung City
China Medical University Hospital /ID# 267631
RECRUITING
Taichung
Taichung Veterans General Hospital /ID# 270467
RECRUITING
Taichung
National Cheng Kung University Hospital /ID# 270468
RECRUITING
Tainan City
Taipei Veterans General Hospital /ID# 267628
RECRUITING
Taipei
National Taiwan University Hospital /ID# 267627
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 267637
RECRUITING
Taoyuan
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2028-10
Participants
Target number of participants: 460
Treatments
Experimental: Stage 1: Telisotuzumab Adizutecan Dose A
Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration.
Experimental: Stage 1: Telisotuzumab Adizutecan Dose B
Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration.
Experimental: Stage 2: Telisotuzumab Adizutecan Optimal Dose
Participants will receive the optimal dose of telisotuzumab adizutecan, as part of the approximately 4 year study duration.
Experimental: Stage 2: Standard of Care (SOC)
Participants will receive the SOC, as part of the approximately 4 year study duration.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

Similar Clinical Trials