Clinical trial • Phase II • Oncology
TELISOTUZUMAB ADIZUTECAN for Metastatic colorectal cancer
Phase II trial of TELISOTUZUMAB ADIZUTECAN for Metastatic colorectal cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic colorectal cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC|Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-02-2025
- First CTIS Authorization Date
- 25-06-2025
Trial design
Randomised, open-label, folinic acid; fluorouracil; oxaliplatin; bevacizumab; panitumumab (doses and schedules not specified in the available data)-controlled, adaptive Phase II trial in Austria, Czechia, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Folinic acid; Fluorouracil; Oxaliplatin; Bevacizumab; Panitumumab (doses and schedules not specified in the available data)
- Adaptive
- True, includes dose optimization to determine the recommended Phase 3 dose (RP3D) in applicable substudies within a master protocol structure; detailed dose-escalation rules/interim analysis/stopping rules not specified in the provided data
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 120
Eligibility
Recruits 120 Vulnerable population is selected (isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms are provided (multiple Main Substudy ICFs, Optional Substudy ICFs, Pregnant Partner ICFs listed in documents). The JSON does not provide detailed text on assent or age-specific consent handling; consent is collected via the listed informed consent documents per country..
- Vulnerable Population
- Vulnerable population is selected (isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms are provided (multiple Main Substudy ICFs, Optional Substudy ICFs, Pregnant Partner ICFs listed in documents). The JSON does not provide detailed text on assent or age-specific consent handling; consent is collected via the listed informed consent documents per country.
Inclusion criteria
- {"criterion_text":"- Substudy 1 and 2: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n- Substudy 1 and 2: QTc < 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.\n- Substudy 1 and 2: Participant has histologically or cytologically confirmed mCRC.\n- Substudy 1 and 2: Participant has measurable disease per RECIST v1.1.\n- Substudy 2: Left sided primary tumor"}
Exclusion criteria
- {"criterion_text":"- Substudy 1 and 2: Prior systemic therapy for mCRC.\n- Substudy 1 and 2: History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis that required treatment with systemic steroids, or idiopathic pneumonitis.\n- Substudy 1 and 2: History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%).\n- Substudy 2: History of treatment with any anti-EGFR treatments (cetuximab or panitumumab)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.","definition_or_measurement_approach":"Objective response assessed by the investigator per RECIST v1.1: confirmed CR or PR. A repeat assessment must confirm response at least 28 days from the first documented response."}
Secondary endpoints
- {"endpoint_text":"- Substudy 1 and 2: Progression-Free Survival as assessed by the investigator: PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.","definition_or_measurement_approach":"PFS defined as time from first dose to first radiographic progression by RECIST v1.1 as determined by investigator or death from any cause."}
- {"endpoint_text":"- Substudy 1 and 2: DOR as assessed by the investigator: The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. DOR is defined for subjects with confirmed CR/PR.","definition_or_measurement_approach":"Duration of Response (DOR): time from first documented CR/PR to first radiographic progression per RECIST v1.1 or death; defined for subjects with confirmed CR/PR."}
- {"endpoint_text":"- Substudy 1 and 2: Overall survival: defined as the time from first dose of study treatment to the event of death from any cause.","definition_or_measurement_approach":"Overall survival: time from first dose to death from any cause."}
- {"endpoint_text":"- Substudy 1 and 2: Disease Control as assessed by the investigator: best overall response of confirmed CR or confirmed PR, or Stable Disease (SD) based on RECIST, version 1.1 as determined by the investigator.","definition_or_measurement_approach":"Disease control: best overall response = confirmed CR or confirmed PR, or Stable Disease (SD) per RECIST v1.1 as determined by investigator."}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 33
- Consent Approach
- Informed consent is obtained using country-specific subject information and informed consent forms. Multiple language/country-specific ICF documents are provided (examples: French, Greek, Italian, Spanish, Czech, Austrian recruitment/ICF documents listed). Documents include Main Substudy ICFs, Optional Substudy ICFs, Pregnant Partner ICFs, and Continuation Treatment ICFs. The JSON does not specify assent procedures for minors; consent is collected from participants via the listed ICFs.
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 104
Austria
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 269
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Department of Internal Medicine, Division of Oncology
- Principal Investigator Name
- Renate Schaberl-Moser
- Principal Investigator Email
- renate.schaberl-moser@medunigraz.at
- Contact Person Name
- Renate Schaberl-Moser
- Contact Person Email
- renate.schaberl-moser@medunigraz.at
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- 3rd Medical Department with Hematology, Medical Oncology, Hemostaseology, Infectious Disease
- Principal Investigator Name
- Lukas Weiss
- Principal Investigator Email
- lu.weiss@salk.at
- Contact Person Name
- Lukas Weiss
- Contact Person Email
- lu.weiss@salk.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Medicine Division of Oncology
- Principal Investigator Name
- Gerald Prager
- Principal Investigator Email
- gerald.prager@meduniwien.ac.at
- Contact Person Name
- Gerald Prager
- Contact Person Email
- gerald.prager@meduniwien.ac.at
Czechia
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 288
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Oncology Clinic
- Principal Investigator Name
- Lucie Zitnanska
- Principal Investigator Email
- lucie.zitnanska@ftn.cz
- Contact Person Name
- Lucie Zitnanska
- Contact Person Email
- lucie.zitnanska@ftn.cz
- Site Name
- Fakultni Nemocnice Motol A Homolka
- Department Name
- Oncology Clinic
- Principal Investigator Name
- Stanislav Batko
- Principal Investigator Email
- stanislav.batko@fnmotol.cz
- Contact Person Name
- Stanislav Batko
- Contact Person Email
- stanislav.batko@fnmotol.cz
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Clinic of Comprehensive Oncological Care
- Principal Investigator Name
- Jiri Tomasek
- Principal Investigator Email
- jiri.tomasek@mou.cz
- Contact Person Name
- Jiri Tomasek
- Contact Person Email
- jiri.tomasek@mou.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Oncology Clinic
- Principal Investigator Name
- Michal Vocka
- Principal Investigator Email
- michal.vocka@vfn.cz
- Contact Person Name
- Michal Vocka
- Contact Person Email
- michal.vocka@vfn.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Oncology and Radiotherapy Clinic
- Principal Investigator Name
- Stanislav John
- Principal Investigator Email
- stanislav.john@fnhk.cz
- Contact Person Name
- Stanislav John
- Contact Person Email
- stanislav.john@fnhk.cz
France
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 309
- Number Of Sites
- 8
- Number Of Participants
- 21
Sites
- Site Name
- Hopitaux Universitaires Pitie Salpetriere
- Department Name
- Hepato gastroenrology and digestive oncology
- Principal Investigator Name
- Jean Baptiste BACHET
- Principal Investigator Email
- jean-baptiste.bachet@psl.aphp.fr
- Contact Person Name
- Jean Baptiste BACHET
- Contact Person Email
- jean-baptiste.bachet@psl.aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hepato gastroenterology and digestive oncology
- Principal Investigator Name
- Julien TAIEB
- Principal Investigator Email
- julien.taieb@aphp.fr
- Contact Person Name
- Julien TAIEB
- Contact Person Email
- julien.taieb@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hepato gastroenterology and oncology
- Principal Investigator Name
- Yann TOUCHEFEU
- Principal Investigator Email
- yann.touchefeu@chu-nantes.fr
- Contact Person Name
- Yann TOUCHEFEU
- Contact Person Email
- yann.touchefeu@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Gastro enterology and medical oncology
- Principal Investigator Name
- David TOUGERON
- Principal Investigator Email
- david.tougeron@chu-poitiers.fr
- Contact Person Name
- David TOUGERON
- Contact Person Email
- david.tougeron@chu-poitiers.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jean Emmanuel MITRY
- Principal Investigator Email
- mitryje@ipc.unicancer.fr
- Contact Person Name
- Jean Emmanuel MITRY
- Contact Person Email
- mitryje@ipc.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Clelia COUTZAC
- Principal Investigator Email
- clelia.coutzac@lyon.unicancer.fr
- Contact Person Name
- Clelia COUTZAC
- Contact Person Email
- clelia.coutzac@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Medical Oncology
- Principal Investigator Name
- Anthony TURPIN
- Principal Investigator Email
- anthony.turpin@chru-lille.fr
- Contact Person Name
- Anthony TURPIN
- Contact Person Email
- anthony.turpin@chru-lille.fr
- Site Name
- Centre Leon Berard (listed twice in dataset contexts)
- Department Name
- Medical Oncology
Greece
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 260
- Number Of Sites
- 8
- Number Of Participants
- 14
Sites
- Site Name
- University General Hospital Attikon
- Department Name
- 4th Department of Internal Medicine
- Principal Investigator Name
- Anna Koumarianou
- Principal Investigator Email
- akoumari@yahoo.com
- Contact Person Name
- Anna Koumarianou
- Contact Person Email
- akoumari@yahoo.com
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Department of Internal Medicine, Section of Medical Oncology
- Principal Investigator Name
- Amanda Psyrri
- Principal Investigator Email
- psyrri237@yahoo.com
- Contact Person Name
- Amanda Psyrri
- Contact Person Email
- psyrri237@yahoo.com
- Site Name
- General Oncological Hospital Of Kifissia Agioi Anargyroi
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Elli Sofia Tripodakis
- Principal Investigator Email
- ellisophiatripodaki@gmail.com
- Contact Person Name
- Elli Sofia Tripodakis
- Contact Person Email
- ellisophiatripodaki@gmail.com
- Site Name
- St. Luke's Hospital S.A.
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Elena Fountzila
- Principal Investigator Email
- elenafou@gmail.com
- Contact Person Name
- Elena Fountzila
- Contact Person Email
- elenafou@gmail.com
- Site Name
- Theageneio Cancer Hospital
- Department Name
- B Chemotherapy Oncology Department
- Principal Investigator Name
- Grigorios Rallis
- Principal Investigator Email
- grrallis@yahoo.com
- Contact Person Name
- Grigorios Rallis
- Contact Person Email
- grrallis@yahoo.com
- Site Name
- Areteio Hospital
- Department Name
- Oncology Unit
- Principal Investigator Name
- Flora Zagouri
- Principal Investigator Email
- florazagouri@yahoo.co.uk
- Contact Person Name
- Flora Zagouri
- Contact Person Email
- florazagouri@yahoo.co.uk
- Site Name
- Metropolitan Hospital
- Department Name
- 4th Oncology Department
- Principal Investigator Name
- Helena Linardou
- Principal Investigator Email
- elinardou@metropolitan-hospital.gr
- Contact Person Name
- Helena Linardou
- Contact Person Email
- elinardou@metropolitan-hospital.gr
- Site Name
- University General Hospital Attikon (additional listed site entry)
- Department Name
- Department not specified
Italy
- Earliest CTIS Part Ii Submission Date
- 11-03-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 346
- Number Of Sites
- 8
- Number Of Participants
- 24
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology
- Principal Investigator Name
- Filippo Pietrantonio
- Principal Investigator Email
- filippo.pietrantonio@istitutotumori.mi.it
- Contact Person Name
- Filippo Pietrantonio
- Contact Person Email
- filippo.pietrantonio@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Precision Medicine
- Principal Investigator Name
- Fortunato Ciardiello
- Principal Investigator Email
- fortunato.ciardiello@unicampania.it
- Contact Person Name
- Fortunato Ciardiello
- Contact Person Email
- fortunato.ciardiello@unicampania.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Giampaolo Tortora
- Principal Investigator Email
- giampaolo.tortora@policlinicogemelli.it
- Contact Person Name
- Giampaolo Tortora
- Contact Person Email
- giampaolo.tortora@policlinicogemelli.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- S.C. Oncologia Medica 1 U
- Principal Investigator Name
- Massimo Di Maio
- Principal Investigator Email
- massimo.dimaio@unito.it
- Contact Person Name
- Massimo Di Maio
- Contact Person Email
- massimo.dimaio@unito.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- U.O. Oncologia Medica 2 Universitaria
- Principal Investigator Name
- Chiara Cremolini
- Principal Investigator Email
- chiaracremolini@gmail.com
- Contact Person Name
- Chiara Cremolini
- Contact Person Email
- chiaracremolini@gmail.com
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- O.U. of Oncology and Hematology
- Principal Investigator Name
- Armando Santoro
- Principal Investigator Email
- armando.santoro@cancercenter.humanitas.it
- Contact Person Name
- Armando Santoro
- Contact Person Email
- armando.santoro@cancercenter.humanitas.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncology Dept
- Principal Investigator Name
- Sara Lonardi
- Principal Investigator Email
- sara.lonardi@iov.veneto.it
- Contact Person Name
- Sara Lonardi
- Contact Person Email
- sara.lonardi@iov.veneto.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Dept. of Hematology, Oncoly, and Molecular Medicine
- Principal Investigator Name
- Federica Tosi
- Principal Investigator Email
- federica.tosi@ospedaleniguarda.it
- Contact Person Name
- Federica Tosi
- Contact Person Email
- federica.tosi@ospedaleniguarda.it
Spain
- Earliest CTIS Part Ii Submission Date
- 07-05-2025
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 288
- Number Of Sites
- 7
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncología
- Principal Investigator Name
- Iosune Baraibar Argota
- Principal Investigator Email
- ibaraibar@vhio.net
- Contact Person Name
- Iosune Baraibar Argota
- Contact Person Email
- ibaraibar@vhio.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncología
- Principal Investigator Name
- Ignacio Matos Garcia
- Principal Investigator Email
- ensayoscun@unav.es
- Contact Person Name
- Ignacio Matos Garcia
- Contact Person Email
- ensayoscun@unav.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncología
- Principal Investigator Name
- Carlos Lopez Lopez
- Principal Investigator Email
- carlos.lopez@scsalud.es
- Contact Person Name
- Carlos Lopez Lopez
- Contact Person Email
- carlos.lopez@scsalud.es
- Site Name
- Clinica Universidad De Navarra (Madrid site)
- Department Name
- Oncología
- Principal Investigator Name
- Ignacio Matos Garcia
- Principal Investigator Email
- ensayoscun@unav.es
- Contact Person Name
- Ignacio Matos Garcia
- Contact Person Email
- ensayoscun@unav.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncología
- Principal Investigator Name
- Susana Rosello Keranen
- Principal Investigator Email
- srosello@incliva.es
- Contact Person Name
- Susana Rosello Keranen
- Contact Person Email
- srosello@incliva.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncología
- Principal Investigator Name
- Nuria Rodriguez Salas
- Principal Investigator Email
- nuria.rodriguez@salud.madrid.org
- Contact Person Name
- Nuria Rodriguez Salas
- Contact Person Email
- nuria.rodriguez@salud.madrid.org
- Site Name
- Clinica Universidad De Navarra (Pamplona site)
- Department Name
- Oncología
- Principal Investigator Name
- Ignacio Matos Garcia
- Principal Investigator Email
- ensayoscun@unav.es
- Contact Person Name
- Ignacio Matos Garcia
- Contact Person Email
- ensayoscun@unav.es
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: [7]
- Name
- Iqvia Rds Inc.
- Responsibilities
- sponsorDuties codes: [3]
- Name
- Veeva Systems Inc.
- Responsibilities
- sponsorDuties codes: [7]
- Name
- Clario Medical Imaging Inc.
- Responsibilities
- Imaging (sponsorDuties code: 15)
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- Central laboratory services (sponsorDuties code: 4)
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"sponsorDuties codes: [15] (Imaging)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Tissue Diagnostics","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- Telisotuzumab adizutecan
- Active Substance
- TELISOTUZUMAB ADIZUTECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 1
- Investigational Product Name
- Folinic acid
- Active Substance
- FOLINIC ACID
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Fluorouracil
- Active Substance
- FLUOROURACIL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Bevacizumab
- Active Substance
- BEVACIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Panitumumab
- Active Substance
- PANITUMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Oxaliplatin
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Combination Treatment
- Yes
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