Colorectal Cancer
Conditions
Interventions
Drug: Telisotuzumab Adizutecan
- Intravenous (IV) Infusion
Drug: Standard of Care
- Standard of care treatment based on investigator's judgement to the active surveillance
Sponsors
Yamagishi Chika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum. - Surgical tumor material should be available and must be submitted for Signatera personalized panel and assessment of c-Met protein levels. - Must have received at least 3 months of platinum-based doublet adjuvant 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. - Circulating tumor deoxyribonucleic acid (ctDNA) positive after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA is confirmed (reported). - For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy. - For participants with oligometastatic disease a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet therapy must have been administered.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark, Italy, Japan, Republic of Korea, Spain, Taiwan, United States of America
Contacts
Public ContactHCP Contact for
AbbVie GK
Outcome results
None listed