Study on the Effects and Safety of Telisotuzumab Adizutecan for Colorectal Cancer Patients with Circulating Tumor DNA
Sponsor: AbbVie
ClinicalTrials ID:NCT07023289
This clinical trial is testing a new drug, Telisotuzumab Adizutecan, to see how it affects disease activity in colorectal cancer patients who have circulating tumor DNA but no visible signs of cancer on scans. The study compares the new drug to standard treatments.
Patient Parameters
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Program Overview
Colorectal cancer is one of the most common cancers worldwide. This study aims to see how well a new drug, Telisotuzumab Adizutecan, works compared to standard treatments for colorectal cancer patients who have circulating tumor DNA but no visible cancer on scans. Participants will be divided into two groups: one will receive the new drug, and the other will receive standard care. The study will last about 51 months and involve around 140 participants at 45 locations worldwide. Participants will have regular check-ups, including medical exams, blood tests, and questionnaires, to monitor the treatment's effects and any side effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with colorectal cancer confirmed by lab tests.
- Must have tumor tissue available for specific testing.
- Completed at least 3 months of a specific type of chemotherapy after surgery.
- No visible cancer on recent CT scans of the chest, abdomen, and pelvis.
- Tested positive for circulating tumor DNA after finishing chemotherapy and start treatment within 6 weeks of this result.
- For rectal cancer patients, at least 3 months of specific chemotherapy must have been given, excluding certain types of radiation.
- For patients with limited spread of cancer, at least 3 months of specific chemotherapy must have been given.
Exclusion Criteria
- No available surgical tissue sample for testing.
- History of lung diseases like interstitial lung disease or pneumonitis that needed steroid treatment, or any signs of these conditions on a recent chest CT scan.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Medical Foundation /ID# 274207 | 92835-3826 | Fullerton | California |
| USC Norris Comprehensive Cancer Center /ID# 274550 | 90033 | Los Angeles | California |
| Johns Hopkins Hospital /ID# 275645 | 21287 | Baltimore | Maryland |
| Scri Minnesota Oncology Hematology, P.A. /ID# 275149 | 55404 | Minneapolis | Minnesota |
| Northwell Health Center for Advanced Medicine. /ID# 275331 | 11042 | Lake Success | New York |
| Northwest Cancer Specialists /ID# 275151 | 97227-1800 | Portland | Oregon |
| SCRI Oncology Partners /ID# 274522 | 37203 | Nashville | Tennessee |
| Texas Oncology - Central/South Texas /ID# 275154 | 78705 | Austin | Texas |
| Texas Oncology-Grapevine /ID# 275155 | 76051 | Grapevine | Texas |
| The University of Texas MD Anderson Cancer Center /ID# 273539 | 77030 | Houston | Texas |
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