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
NCT ID: NCT07196644
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
125 participants
INTERVENTIONAL
2025-12-04
2030-12-31
Brief Summary
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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 125 participants 12 years of age or older. with solid tumors harboring MET amplification will be enrolled in the study in up to 55 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Telisotuzumab Adizutecan
Participants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration.
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Interventions
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Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Eligibility Criteria
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Inclusion Criteria
* 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) 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
* Any major, life-threatening conditions and life expectancy should be at least 12 weeks.
12 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Valkyrie Clinical Trials /ID# 275547
Los Angeles, California, United States
University of Chicago Medical Center /ID# 275342
Chicago, Illinois, United States
START Midwest /ID# 276603
Grand Rapids, Michigan, United States
Duke Cancer Institute /ID# 275604
Durham, North Carolina, United States
South Texas Accelerated Research Therapeutics (START) /ID# 276608
San Antonio, Texas, United States
Start Mountain Region /ID# 276607
West Valley City, Utah, United States
The Chaim Sheba Medical Center /ID# 274342
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 274344
Tel Aviv, Tel Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 274343
Jerusalem, , Israel
Rabin Medical Center. /ID# 274341
Petah Tikva, , Israel
Nagoya University Hospital /ID# 276336
Nagoya, Aichi-ken, Japan
Hokkaido University Hospital /ID# 276333
Sapporo, Hokkaido, Japan
Kyoto University Hospital /ID# 276398
Kyoto, Kyoto, Japan
Okayama University Hospital /ID# 276299
Okayama, Okayama-ken, Japan
National Cancer Center Hospital /ID# 276297
Chuo-Ku, Tokyo, Japan
Samsung Medical Center /ID# 275705
Seoul, Seoul Teugbyeolsi, South Korea
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2024-518871-74
Identifier Type: OTHER
Identifier Source: secondary_id
M25-279
Identifier Type: -
Identifier Source: org_study_id