A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
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.
Circulating tumor deoxyribonucleic acid (ctDNA) positive within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity 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.
You may not be if
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.
Clareo Health | A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
