Study on the Safety and Effectiveness of Telisotuzumab Adizutecan with Chemotherapy and Other Drugs for Metastatic Colorectal Cancer
Sponsor: AbbVie
ClinicalTrials ID:NCT06820463
This clinical trial is testing a new drug, telisotuzumab adizutecan, in combination with chemotherapy and other medications to see if it is safe and effective for treating metastatic colorectal cancer (mCRC).
Patient Parameters
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Program Overview
Colorectal cancer (CRC) is one of the most common cancers worldwide, especially in developed countries. This study aims to find out if a new drug, telisotuzumab adizutecan, is safe and can help control the disease when used with other chemotherapy drugs like oxaliplatin, fluorouracil (5FU), leucovorin (LV), and either bevacizumab or panitumumab. The study will have two parts. In the first part, participants will receive increasing doses of telisotuzumab adizutecan with the other drugs to find a safe and effective dose. In the second part, participants will be divided into three groups to receive different combinations of these drugs. About 390 adults with metastatic colorectal cancer will participate in this study at 100 locations worldwide. The study will last about 6 years, and participants will have regular check-ups, blood tests, and other assessments to monitor the treatment's effects and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have specific lab test results that meet the study's requirements.
- Must have cancer that can be measured using standard criteria.
Exclusion Criteria
- Cannot have previously received treatments that target c-Met or topoisomerase inhibitors.
- Cannot have had any other cancers in the past 5 years, except for those with a very low risk of spreading or causing death.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale New Haven Hospital /ID# 270565 | 06510 | New Haven | Connecticut |
| Hope And Healing Cancer Services /ID# 271562 | 60521 | Hinsdale | Illinois |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646 | 68130 | Omaha | Nebraska |
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