A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan

Study Identifier
M25-279
CT.gov Identifier
NCT07196644
EudraCT Identifier
Not available
EUCTIS ID
2024-518871-74-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Solid Tumors (General)
    • Study Drug
  • Telisotuzumab Adizutecan
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    12+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Locally advanced/metastatic solid tumors with documented MET amplification via Local next generation sequencing (NGS) or Central NGS via FoundationOne Companion Diagnostic (F1CDx). * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) 2.0 criteria as appropriate to tumor type. * Received prior systemic therapy appropriate for their tumor type and stage of disease and who have no satisfactory alternative therapy for advanced solid tumors that would be expected to provide a substantial survival benefit for their tumor type. * If participant has central nervous system (CNS) metastasis, these should be clinically asymptomatic or radiologically stable (i.e., without evidence of progression after definitive treatment).
    Exclusion Criteria:
    * Current, historical, or suspected (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids. * Any major, life-threatening conditions and life expectancy should be at least 12 weeks.

    Protocol Summary

    Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan.

    Telisotuzumab adizutecan is an investigational drug being developed for the treatment of locally advanced or metastatic solid tumors that harbor MET amplification. This study will have 1 arm where participants will receive telisotuzumab adizutecan. Approximately 100 participants 12 years of age or older. with solid tumors harboring MET amplification will be enrolled in the study in up to 50 sites around the world.

    Participants will receive intravenous (IV) telisotuzumab adizutecan, as part of the 61.5 month study duration.

    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
    Beverly Hills Cancer Center /ID# 275465
    Beverly Hills, California, United States, 90211
    Status
    Recruiting
    Location
    City of Hope National Medical Center /ID# 275613
    Duarte, California, United States, 91010
    Status
    Recruiting
    Location
    Valkyrie Clinical Trials /ID# 275547
    Los Angeles, California, United States, 90067
    Status
    Recruiting
    Location
    Yale University School of Medicine /ID# 275978
    New Haven, Connecticut, United States, 06510
    Status
    Recruiting
    Location
    Florida Cancer Specialists - North /ID# 277137
    St. Petersburg, Florida, United States, 33705
    Status
    Recruiting
    Location
    Northwestern University Feinberg School of Medicine /ID# 276436
    Chicago, Illinois, United States, 60611-2927
    Status
    Recruiting
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