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
- Diseases
- Colorectal cancer
- 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
Sites (91)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mater Misericordiae /ID# 268360 Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Completed |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Completed |
| Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Complejo Hospitalario Universitario de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Completed |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Rambam Health Care Campus- Haifa /ID# 267739 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center-Hebrew University /ID# 267579 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center. /ID# 267740 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 267741 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Assuta Medical Center - Tel Aviv /ID# 267745 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 267578 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| ARNAS Garibaldi Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Completed |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Completed |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Completed |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Completed |
| National Cancer Center Hospital /ID# 268713 Coordinator of this site? Confirm its status | Chuo-Ku | Japan | Unknown status |
| National Cancer Center Hospital East /ID# 268236 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Saitama Prefectural Cancer Center /ID# 268706 Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| Aichi Cancer Center /ID# 268237 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| The University of Osaka Hospital /ID# 268743 Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Seoul National University Bundang Hospital /ID# 268592 Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Seoul National University Hospital /ID# 268719 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University Health System Severance Hospital /ID# 268718 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center /ID# 268720 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center /ID# 268717 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Frisius MC Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Completed |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Completed |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego Coordinator of this site? Confirm its status | Grudziądz | Poland | Completed |
| Umed Clinical Trials Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Pan American Center for Oncology Trials - Rio Piedras /ID# 267888 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Changhua Christian Hospital /ID# 270464 Coordinator of this site? Confirm its status | Changhua City, Changhua County | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital /ID# 267638 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital /ID# 267631 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital /ID# 270467 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital /ID# 270468 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital /ID# 267628 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital /ID# 267627 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital /ID# 267637 Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Winship Cancer Institute of Emory University /ID# 266884 Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185 Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| St. Luke's Cancer Institute: Boise /ID# 268095 Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| University of North Carolina Medical Center /ID# 266879 Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Virginia /ID# 268108 Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Texas - Southwestern Medical Center /ID# 268241 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| City of Hope National Medical Center /ID# 267875 Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke University Medical Center /ID# 267966 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| West Cancer Center and Research Institute - Germantown /ID# 268619 Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175 Coordinator of this site? Confirm its status | Golden | United States | Unknown status |
| Hattiesburg Clinic /ID# 267860 Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Hope And Healing Cancer Services /ID# 268541 Coordinator of this site? Confirm its status | Hinsdale | United States | Unknown status |
| Millennium Physicians /ID# 268400 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| The University of Texas MD Anderson Cancer Center /ID# 268098 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Community Cancer Center North /ID# 267965 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655 Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| USC Norris Comprehensive Cancer Center /ID# 268131 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey /ID# 268056 Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Smilow Cancer Center At Yale-New Haven /ID# 269125 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| AdventHealth Orlando /ID# 267970 Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Avera Cancer Institute - Sioux Falls /ID# 268074 Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Springfield Clinic - First /ID# 268666 Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Washington University /ID# 267872 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.