Comparing IV telisotuzumab adizutecan versus standard care for colorectal cancer patients who are ctDNA-positive with no visible disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 interventional trial enrolls about 140 adults with resected colorectal adenocarcinoma who are ctDNA-positive after finishing adjuvant platinum-based chemotherapy and have no radiographic evidence of disease. Participants are assigned to one of two arms: intravenous telisotuzumab adizutecan alone or standard of care alone, with tumor tissue submitted for biomarker (c-Met) testing and personalized ctDNA panel confirmation. The study monitors safety (adverse events) and change in disease activity over a planned duration of roughly 51 months, with regular on-site visits for infusions and follow-up imaging and blood tests. The protocol includes requirements for available surgical tumor material and timely start of treatment after ctDNA confirmation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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.

Where it's running

• Providence Medical Foundation - Fullerton /ID# 274207
  Fullerton, California, United States Recruiting
• USC Norris Comprehensive Cancer Center /ID# 274550
  Los Angeles, California, United States Recruiting
• Mayo Clinic Hospital Jacksonville /ID# 274472
  Jacksonville, Florida, United States Recruiting
• Moffitt Cancer Center /ID# 274372
  Tampa, Florida, United States Recruiting
• University of Chicago Medical Center /ID# 274742
  Chicago, Illinois, United States Recruiting
• Johns Hopkins Hospital /ID# 275645
  Baltimore, Maryland, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.