Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Intravenous (IV) Infusion
Standard of care treatment based on investigator's judgement to the active surveillance.
Providence Medical Foundation /ID# 274207
Fullerton, California, United States
RECRUITINGUSC Norris Comprehensive Cancer Center /ID# 274550
Los Angeles, California, United States
RECRUITINGMayo Clinic Hospital Jacksonville /ID# 274472
Jacksonville, Florida, United States
RECRUITINGUniversity of Chicago Medical Center /ID# 274742
Chicago, Illinois, United States
Percentage of Participants with disease free survival (DFS) Event
DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.
Time frame: Up to Approximately 51 Months
Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
ctDNA clearance at 6 months is defined as ctDNA negative at 6 months after randomization.
Time frame: 6 Months
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Time frame: Up to Approximately 51 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Johns Hopkins Hospital /ID# 275645
Baltimore, Maryland, United States
RECRUITINGUniversity Of Michigan /ID# 273511
Ann Arbor, Michigan, United States
RECRUITINGScri Minnesota Oncology Hematology, P.A. /ID# 275149
Minneapolis, Minnesota, United States
RECRUITINGMayo Clinic-Rochester /ID# 273508
Rochester, Minnesota, United States
RECRUITINGNorthwell Health Center for Advanced Medicine. /ID# 275331
Lake Success, New York, United States
RECRUITINGNorthwest Cancer Specialists /ID# 275151
Portland, Oregon, United States
RECRUITING...and 27 more locations