A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

Launched by ABBVIE · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with a specific type of advanced colorectal cancer known as c-Met over-expressed refractory metastatic colorectal cancer. The researchers want to see how safe and effective a drug called ABBV-400, given through an IV, is compared to a standard treatment that includes oral tablets called LONSURF along with another IV drug called bevacizumab. The trial will involve about 460 adult participants from various countries, and it will take place over roughly four years.

To be eligible for this trial, participants should have a life expectancy of at least 12 weeks and a good performance status, meaning they are relatively well and able to carry out daily activities. They should also have measurable disease based on specific medical criteria. Those taking part can expect to have regular visits at a hospital or clinic, where their health will be closely monitored through tests and assessments to check for any side effects or improvements in their condition. It’s important to note that participating in this trial may require more frequent visits and treatments than standard care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Life expectancy \>= 12 weeks per investigator assessment.
• • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
• • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
• Exclusion Criteria:
• • Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate \[ADC\]).
• • History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
• • Active infection as noted in the protocol.