An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

UVA Tracking #
301907
Principal Investigator
Matthew J Reilley
Contact
Contact Phone
Official Trial Title
An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
Study Description

The University of Virginia is participating in a clinical research study for adults ages 18 and over, who have been diagnosed with Colorectal Cancer and have evidence of c-Met overexpression (the level of c-Met protein in your tumor cells is increased). The purpose of this study is to determine the recommended ABBV-400 dose when ABBV-400 is given alone (monotherapy) in Stage 1, and to assess if the investigational medicine, ABBV-400 monotherapy, is a safe and effective treatment compared to the standard of care (SOC) LONSURF [Trifluridine and Tipiracil] plus Bevacizumab in subjects with c-Met overexpressed (level of c-Met protein in your tumor cells is increased) uncontrolled metastatic colorectal cancer in Stage 2 of the study plan.

If enrolled, you will receive treatment as long as your cancer is responding to the treatment, or until your disease gets worse (unless otherwise decided by your study doctor), you experience unacceptable side effects, you withdraw your consent, you start a different anticancer treatment, the study doctor believes you are no longer receiving benefit from the study drug, or any other discontinuation criteria occur. Following treatment you will be contacted approximately every 3 months to see how you are doing and if you have started any new anti-cancer treatments.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/study/NCT06614192

uvacancertrials@hscmail.mcc.virginia.edu

The (department, division name) seeks (insert as applies: adults/men/women/adolescents/children) ages (insert) with (insert condition) for a research study. The purpose of the study is (insert purpose of study - eg.to test the effectiveness of an investigational medicine; or to find out how stress effects blood pressure.)

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Study involves (insert procedures-examples: taking an experimental medicine/placebo, blood draws, x rays, overnight stays,) (Insert x number of visits every x (weeks, months,) each visit lasting x amount of time or give range).

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Compensation

No Compensation