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

Launched by ABBVIE · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called telisotuzumab adizutecan for adults with colorectal cancer (CRC) who have no visible signs of the disease but have detectable cancer DNA in their blood. The trial will compare the effects of this new treatment given alone to the standard treatment currently available. About 140 adults will participate in this trial across 45 locations around the world. Participants will be placed in one of two groups: one will receive telisotuzumab adizutecan through an intravenous (IV) line, while the other will receive standard treatment alone.

To be eligible for this trial, participants must have a specific type of colorectal cancer, have previously received certain chemotherapy treatments, and have a confirmed positive test for circulating tumor DNA. They will also need to provide tumor tissue for testing. Throughout the trial, participants will have regular check-ups at a hospital or clinic to monitor their health, including blood tests and questionnaires about any side effects. It’s important to note that this trial may involve more frequent visits and treatments than standard care.

Gender

ALL

Eligibility 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:
• • 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.