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

Study Identifier
M24-064
CT.gov Identifier
NCT06614192
EudraCT Identifier
Not available
EUCTIS ID
2024-512804-20-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Colorectal Cancer
    • Study Drug
  • Telisotuzumab Adizutecan
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and 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.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    City of Hope National Medical Center /ID# 267875
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    USC Norris Comprehensive Cancer Center /ID# 268131
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
    Golden, Colorado, United States, 80401
    Status
    Not applicable
    Location
    Yale University School of Medicine /ID# 269125
    New Haven, Connecticut, United States, 06510
    Status
    Not applicable
    Location
    AdventHealth Orlando /ID# 267970
    Orlando, Florida, United States, 32803
    Status
    Not applicable
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