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NCT07196644RecruitingPhase 2

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

A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
22 Sept 2025
Start date
1 Dec 2025
Primary completion date
31 Dec 2030
Lead sponsor
AbbVie
NCT number
NCT07196644
EU CT number
2024-518871-74-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • From 1 Dec 2025 to the primary completion date, 31 Dec 2030
  • 43 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rigshospitalet
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Copenhagen OeDenmarkNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Hadassah Medical Center-Hebrew University /ID# 274343
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JerusalemIsraelRecruiting
Rabin Medical Center. /ID# 274341
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Petah TikvaIsraelRecruiting
The Chaim Sheba Medical Center /ID# 274342
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Ramat GanIsraelRecruiting
Tel Aviv Sourasky Medical Center /ID# 274344
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Tel AvivIsraelRecruiting
National Cancer Center Hospital /ID# 276297
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Chuo-KuJapanRecruiting
Kyushu University Hospital /ID# 276302
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FukuokaJapanRecruiting
National Cancer Center Hospital East /ID# 276298
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Kashiwa-shiJapanRecruiting
Kyoto University Hospital /ID# 276398
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KyotoJapanRecruiting
Nagoya University Hospital /ID# 276336
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NagoyaJapanRecruiting
Okayama University Hospital /ID# 276299
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OkayamaJapanRecruiting
Hokkaido University Hospital /ID# 276333
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SapporoJapanRecruiting
Tohoku University Hospital /ID# 276344
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SendaiJapanRecruiting
Seoul National University Hospital /ID# 275703
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SeoulSouth KoreaRecruiting
Samsung Medical Center /ID# 275705
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SeoulSouth KoreaRecruiting
Yonsei University Health System Severance Hospital /ID# 276184
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SeoulSouth KoreaRecruiting
Dell Seton Medical Center /ID# 276474
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AustinUnited StatesRecruiting
Beverly Hills Cancer Center /ID# 275465
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Beverly HillsUnited StatesRecruiting
Northwestern University Feinberg School of Medicine /ID# 276436
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ChicagoUnited StatesRecruiting
University of Chicago Medical Center /ID# 275342
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ChicagoUnited StatesRecruiting
University of Texas - Southwestern Medical Center /ID# 276053
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DallasUnited StatesRecruiting
City of Hope National Medical Center /ID# 275613
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DuarteUnited StatesRecruiting
Duke Cancer Institute /ID# 275604
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DurhamUnited StatesRecruiting
Virginia Cancer Specialists - Fairfax /ID# 276010
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FairfaxUnited StatesRecruiting
START Midwest /ID# 276603
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Grand RapidsUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center /ID# 275663
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HoustonUnited StatesRecruiting
Valkyrie Clinical Trials /ID# 275547
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Los AngelesUnited StatesRecruiting
SCRI Oncology Partners /ID# 275686
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NashvilleUnited StatesRecruiting
Yale University School of Medicine /ID# 275978
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New HavenUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 275999
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New YorkUnited StatesRecruiting
Stanford University - Palo Alto /ID# 282083
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Palo AltoUnited StatesRecruiting
South Texas Accelerated Research Therapeutics /ID# 276608
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San AntonioUnited StatesRecruiting
Florida Cancer Specialists - North /ID# 277137
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St. PetersburgUnited StatesRecruiting
Start Mountain Region /ID# 276607
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West Valley CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.