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.
Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
Surgical tumor material should be available for Signatera ctDNA personalized panel design.
Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy.
Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.
No availability of surgical tissue sample.
History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
Parallel
Telisotuzumab Adizutecan
DrugIntravenous (IV) Infusion
Standard of Care
DrugStandard of care treatment based on investigator's judgement to the active surveillance.
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.
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.
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
