Home › Trials › NCT06614192

Comparing ABBV-400 to LONSURF and Bevacizumab for Metastatic Colorectal Cancer

AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

Phase 3 Interventional AbbVie · NCT06614192

This study is testing a new drug called ABBV-400 to see if it works better than the standard treatment of LONSURF and Bevacizumab for adults with hard-to-treat metastatic colorectal cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsbevacizumab, telisotuzumab
Locations51 sites (Duarte, California and 50 other locations)
Trial IDNCT06614192 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of ABBV-400, an investigational drug, compared to the standard treatment of LONSURF oral tablets and IV infused Bevacizumab in adults with c-Met over-expressed refractory metastatic colorectal cancer. Participants will be randomly assigned to different treatment arms, receiving either ABBV-400 or LONSURF plus Bevacizumab. The study will be conducted in two stages, with the first stage determining the optimal dose of ABBV-400 and the second stage comparing it to the standard treatment. Approximately 460 participants will be enrolled across 160 sites in 15-20 countries.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with c-Met over-expressed refractory metastatic colorectal cancer who have a life expectancy of at least 12 weeks.

Not a fit: Patients who have previously received systemic treatment containing c-MET targeting antibodies or have a history of allergic reactions to the study drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with refractory metastatic colorectal cancer that may improve disease management and outcomes.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific comparison of ABBV-400 to LONSURF and Bevacizumab is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Duarte, California and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Colorectal CancerTelisotuzumab AdizutecanABBV-400TrifluridineTipiracilLONSURFBevacizumabAndroMETa-CRC-064
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.