BridgeMD
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 Refractory Metastatic Colorectal Cancer expressing c-Met Protein Level Above Cutoff
EU CTIS ID: 2024-512804-20-00
What this study is testing
Stage 1: To optimize telisotuzumab adizutecan monotherapy dose to determine the recommended dose in participants with unresectable refractory metastatic colorectal cancer (mCRC) selected for the defined level of c-Met protein expression; To evaluate the efficacy of telisotuzumab adizutecan monotherapy dose as measured by objective response (OR) in participants with unresectable refractory mCRC selected for the defined level of c-Met protein expression.; To evaluate the safety of telisotuzumab adizutecan monotherapy in participants with unresectable refractory mCRC selected for the defined level of c-Met protein expression; Stage 2: To demonstrate the superiority of telisotuzumab adizutecan over LONSURF (Trifluridine and Tipiracil) plus bevacizumab in terms of objective response (OR); To demonstrate the superiority of telisotuzumab adizutecan over LONSURF (Trifluridine and Tipiracil) plus bevacizumab in terms of overall survival (OS).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Brazil
- Chile
- United States
- United Kingdom
- Kazakhstan
- Taiwan
- Canada
- Turkey
- Puerto Rico
- Korea, Republic of
- Australia
- Israel
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Brazil; Chile; United States; United Kingdom; Kazakhstan and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.