A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

Running, not enrolling · Phase 3

Conditions studied: Metastatic Colorectal Cancer

In brief

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries. Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. The total study duration will be approximately 4 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key facts

Study ID

NCT06614192

Run by

AbbVie

People needed

74

Starts

2024-11-08

Expected to finish

2027-08-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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.

Where it is running

• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655 — Irvine, California, United States
• USC Norris Comprehensive Cancer Center /ID# 268131 — Los Angeles, California, United States
• Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175 — Golden, Colorado, United States
• Yale University School of Medicine /ID# 269125 — New Haven, Connecticut, United States
• AdventHealth Orlando /ID# 267970 — Orlando, Florida, United States
• Winship Cancer Institute of Emory University /ID# 266884 — Atlanta, Georgia, United States
• St. Luke's Cancer Institute: Boise /ID# 268095 — Boise, Idaho, United States
• Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610 — Chicago, Illinois, United States
• Hope And Healing Cancer Services /ID# 268541 — Hinsdale, Illinois, United States
• Springfield Clinic - First /ID# 268666 — Springfield, Illinois, United States
• Community Cancer Center North /ID# 267965 — Indianapolis, Indiana, United States
• Hattiesburg Clinic /ID# 267860 — Hattiesburg, Mississippi, United States
• Washington University /ID# 267872 — St Louis, Missouri, United States
• Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185 — Billings, Montana, United States
• Rutgers Cancer Institute of New Jersey /ID# 268056 — New Brunswick, New Jersey, United States
• University of North Carolina Medical Center /ID# 266879 — Chapel Hill, North Carolina, United States
• Duke University Medical Center /ID# 267966 — Durham, North Carolina, United States
• Avera Cancer Institute - Sioux Falls /ID# 268074 — Sioux Falls, South Dakota, United States
• West Cancer Center and Research Institute - Germantown /ID# 268619 — Germantown, Tennessee, United States
• University of Texas - Southwestern Medical Center /ID# 268241 — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center /ID# 268098 — Houston, Texas, United States
• Millennium Physicians /ID# 268400 — Houston, Texas, United States
• University of Virginia /ID# 268108 — Charlottesville, Virginia, United States
• Mater Hospital Brisbane /ID# 268360 — South Brisbane, Queensland, Australia
• City of Hope National Medical Center /ID# 267875 — Duarte, California, United States

Full record on ClinicalTrials.gov

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