Telisotuzumab Adizutecan with Bevacizumab vs LONSURF with Bevacizumab in refractory metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares two treatment strategies for adults with refractory metastatic colorectal cancer. Participants are randomized to receive intravenous telisotuzumab adizutecan plus bevacizumab in one arm or the standard care of trifluridine/tipiracil (LONSURF) plus bevacizumab in the other arm. The study aims to evaluate safety and how the disease responds to the regimens. Up to about 990 participants will be enrolled across approximately 125 sites worldwide. Primary outcomes include adverse events and change in disease activity between the two treatment approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
* Life expectancy \>= 12 weeks per investigator assessment

Exclusion Criteria:

* Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC.
* History of intolerance, allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. This also includes patients with known rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
* History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

Where it's running

• City Of Hope - Phoenix /ID# 279450
  Goodyear, Arizona, United States Recruiting
• Highlands Oncology Group - Springdale /ID# 279444
  Springdale, Arkansas, United States Recruiting
• City of Hope National Medical Center /ID# 279449
  Duarte, California, United States Recruiting
• Rocky Mountain Cancer Centers - Aurora /ID# 280112
  Aurora, Colorado, United States Recruiting
• Yale University School of Medicine /ID# 279373
  New Haven, Connecticut, United States Recruiting
• Moffitt Cancer Center /ID# 279325
  Tampa, Florida, United States Recruiting

+38 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.