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A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 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# 270255
Duarte, California, United States
Yale New Haven Hospital /ID# 270565
New Haven, Connecticut, United States
Hope And Healing Cancer Services /ID# 271562
Hinsdale, Illinois, United States
Dana-Farber Cancer Institute /ID# 270624
Boston, Massachusetts, United States
Saint Lukes Hospital of Kansas City /ID# 270633
Kansas City, Missouri, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Omaha, Nebraska, United States
University of North Carolina Medical Center /ID# 267786
Chapel Hill, North Carolina, United States
Oncology Hematology Care - Eastgate /ID# 271493
Cincinnati, Ohio, United States
Texas Oncology - Austin Midtown /ID# 271354
Austin, Texas, United States
Texas Oncology - Deke Slayton Cancer Center /ID# 271355
Webster, Texas, United States
Start Date
April 24, 2025
Primary Completion Date
March 1, 2028
Completion Date
April 1, 2028
Last Updated
March 12, 2026
390
ESTIMATED participants
Telisotuzumab Adizutecan
DRUG
Fluorouracil
DRUG
Oxaliplatin
DRUG
Leucovorin
DRUG
Bevacizumab
DRUG
Panitumumab
DRUG
Lead Sponsor
AbbVie
NCT04657068
NCT06625775
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.
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