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NCT06614192Active, not recruitingPhase 2

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

AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

Source: ClinicalTrials.gov · Last updated 23 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
74 (actual)
First submitted
25 Sept 2024
Start date
8 Nov 2024
Primary completion date
Aug 2027
Lead sponsor
AbbVie
NCT number
NCT06614192
EU CT number
2024-512804-20-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 74
  • From 8 Nov 2024 to the primary completion date, Aug 2027
  • 91 sites in 13 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.

Prior treatment

  • Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate \[ADC\]).

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (91)

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

SiteCityCountrySite status
Mater Misericordiae /ID# 268360
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South BrisbaneAustraliaUnknown status
Klinikum Chemnitz gGmbH
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ChemnitzGermanyCompleted
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyCompleted
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyCompleted
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
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HamburgGermanyCompleted
Heidelberg University
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MannheimGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Hospital del Mar
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BarcelonaSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Complejo Hospitalario Universitario de Ourense
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OurenseSpainCompleted
Hospital Universitario de Navarra
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PamplonaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Institut Bergonie
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BordeauxFranceCompleted
CHRU De Nancy
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Nancy CedexFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Rambam Health Care Campus- Haifa /ID# 267739
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HaifaIsraelUnknown status
Hadassah Medical Center-Hebrew University /ID# 267579
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JerusalemIsraelUnknown status
Rabin Medical Center. /ID# 267740
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 267741
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Ramat GanIsraelUnknown status
Assuta Medical Center - Tel Aviv /ID# 267745
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Tel AvivIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 267578
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Tel AvivIsraelUnknown status
ARNAS Garibaldi Di Catania
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CataniaItalyCompleted
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyCompleted
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Istituto Nazionale dei Tumori
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MilanItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyCompleted
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyCompleted
National Cancer Center Hospital /ID# 268713
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Chuo-KuJapanUnknown status
National Cancer Center Hospital East /ID# 268236
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Kashiwa-shiJapanUnknown status
Saitama Prefectural Cancer Center /ID# 268706
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Kitaadachi-gunJapanUnknown status
Aichi Cancer Center /ID# 268237
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NagoyaJapanUnknown status
The University of Osaka Hospital /ID# 268743
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Suita-shiJapanUnknown status
Seoul National University Bundang Hospital /ID# 268592
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Seongnam-siSouth KoreaUnknown status
Seoul National University Hospital /ID# 268719
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SeoulSouth KoreaUnknown status
Yonsei University Health System Severance Hospital /ID# 268718
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SeoulSouth KoreaUnknown status
Samsung Medical Center /ID# 268720
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SeoulSouth KoreaUnknown status
Asan Medical Center /ID# 268717
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SeoulSouth KoreaUnknown status
Amsterdam UMC Stichting
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AmsterdamNetherlandsCompleted
Frisius MC
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LeeuwardenNetherlandsCompleted
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsCompleted
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandCompleted
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
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GrudziądzPolandCompleted
Umed Clinical Trials Sp. z o.o.
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LodzPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Pan American Center for Oncology Trials - Rio Piedras /ID# 267888
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Rio PiedrasPuerto RicoUnknown status
Changhua Christian Hospital /ID# 270464
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Changhua City, Changhua CountyTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital /ID# 267638
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital /ID# 267631
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital /ID# 270467
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital /ID# 270468
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TainanTaiwanUnknown status
Taipei Veterans General Hospital /ID# 267628
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TaipeiTaiwanUnknown status
National Taiwan University Hospital /ID# 267627
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital /ID# 267637
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Taoyuan CityTaiwanUnknown status
Winship Cancer Institute of Emory University /ID# 266884
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AtlantaUnited StatesUnknown status
Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185
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BillingsUnited StatesUnknown status
St. Luke's Cancer Institute: Boise /ID# 268095
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BoiseUnited StatesUnknown status
University of North Carolina Medical Center /ID# 266879
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Chapel HillUnited StatesUnknown status
University of Virginia /ID# 268108
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CharlottesvilleUnited StatesUnknown status
Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610
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ChicagoUnited StatesUnknown status
University of Texas - Southwestern Medical Center /ID# 268241
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DallasUnited StatesUnknown status
City of Hope National Medical Center /ID# 267875
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DuarteUnited StatesUnknown status
Duke University Medical Center /ID# 267966
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DurhamUnited StatesUnknown status
West Cancer Center and Research Institute - Germantown /ID# 268619
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GermantownUnited StatesUnknown status
Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
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GoldenUnited StatesUnknown status
Hattiesburg Clinic /ID# 267860
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HattiesburgUnited StatesUnknown status
Hope And Healing Cancer Services /ID# 268541
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HinsdaleUnited StatesUnknown status
Millennium Physicians /ID# 268400
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HoustonUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center /ID# 268098
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HoustonUnited StatesUnknown status
Community Cancer Center North /ID# 267965
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IndianapolisUnited StatesUnknown status
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
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IrvineUnited StatesUnknown status
USC Norris Comprehensive Cancer Center /ID# 268131
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Los AngelesUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey /ID# 268056
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New BrunswickUnited StatesUnknown status
Smilow Cancer Center At Yale-New Haven /ID# 269125
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New HavenUnited StatesUnknown status
AdventHealth Orlando /ID# 267970
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OrlandoUnited StatesUnknown status
Avera Cancer Institute - Sioux Falls /ID# 268074
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Sioux FallsUnited StatesUnknown status
Springfield Clinic - First /ID# 268666
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SpringfieldUnited StatesUnknown status
Washington University /ID# 267872
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St LouisUnited StatesUnknown status

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