Clinical trial • Phase II • Oncology
TELISOTUZUMAB ADIZUTECAN for Colorectal cancer
Phase II trial of TELISOTUZUMAB ADIZUTECAN for Colorectal cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colorectal cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC
Key dates
- Initial CTIS Submission Date
- 16-04-2025
- First CTIS Authorization Date
- 29-07-2025
Trial design
Randomised, open-label, current standard of care (not specified in application documents).-controlled Phase II trial across 12 sites in Denmark, Italy, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Current standard of care (not specified in application documents).
- Target Sample Size
- 98
Eligibility
Recruits 98 No vulnerable populations selected. The trial population is adult participants only. Informed consent will be obtained using subject information and informed consent forms (country-specific ICFs and prescreen/optional/pregnant-partner ICFs are provided in the documentation)..
- Vulnerable Population
- No vulnerable populations selected. The trial population is adult participants only. Informed consent will be obtained using subject information and informed consent forms (country-specific ICFs and prescreen/optional/pregnant-partner ICFs are provided in the documentation).
Inclusion criteria
- {"criterion_text":"- Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.\n- Surgical tumor material should be available and must be submitted for Signatera™ personalized panel and assessment of c-Met protein levels.\n- Must have received at least 3 months of platinum-based doublet adjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy.\n- Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.\n- Circulating tumor deoxyribonucleic acid (ctDNA) positive after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA is confirmed (reported)."}
Exclusion criteria
- {"criterion_text":"- No availability of surgical tissue sample.\n- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.\n- Treated or untreated brain or meningeal metastases."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percentage of Participants with disease free survival (DFS) Event","definition_or_measurement_approach":"To be measured by disease free survival (DFS) by investigator."}
Secondary endpoints
- {"endpoint_text":"- Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months","definition_or_measurement_approach":"Measured as ctDNA clearance rate at 6 months (as stated in secondary objectives)."}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Measured as overall survival (OS)."}
Recruitment
- Planned Sample Size
- 98
- Recruitment Window Months
- 48
- Consent Approach
- Informed consent obtained from adult participants via country-specific informed consent forms. Multiple ICF documents are provided (prescreen ICF, main ICF, optional ICF, pregnant partner ICF) and country/language-specific ICFs are available (documents present for Denmark, Italy, Spain, Belgium with languages including Danish, Italian, Spanish, English, French, Dutch).
Methods
- Recruitment brochures / patient brochures (country-specific patient brochures listed: BE Dutch/French/English, ES, IT, DK).
- HCP-to-HCP letters (document: HCPtoHCPletter_Public).
- Site-based recruitment via participating hospitals/oncology clinics (site lists provided per country).
- Third-party patient recruitment (Massive Bio Inc. listed with role: Patient recruitment).
- Country-specific 'Recruitment and ICF Procedures' documents (K1 documents) describing local recruitment arrangements.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 24
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-07-2025
- Latest Decision Or Authorization Date
- 29-07-2025
- Processing Time Days
- 12
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Sygehus Lillebaelt Vejle Sygehus
- Department Name
- Oncology
- Principal Investigator Name
- Lise Ventzel
- Principal Investigator Email
- lise.ventzel@rsyd.dk
- Contact Person Name
- Lise Ventzel
- Contact Person Email
- lise.ventzel@rsyd.dk
- Site Name
- Odense University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Line Tarpgaard
- Principal Investigator Email
- line.tarpgaard@rsyd.dk
- Contact Person Name
- Line Tarpgaard
- Contact Person Email
- line.tarpgaard@rsyd.dk
- Site Name
- Region Midtjylland
- Department Name
- Oncology
- Principal Investigator Name
- Karen-Lise Garm Spindler
- Principal Investigator Email
- k.g.spindler@oncology.au.dk
- Contact Person Name
- Karen-Lise Garm Spindler
- Contact Person Email
- k.g.spindler@oncology.au.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 02-07-2025
- Latest Decision Or Authorization Date
- 30-07-2025
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Clinical Oncology
- Principal Investigator Name
- Lorenzo Antonuzzo
- Principal Investigator Email
- lorenzo.antonuzzo@unifi.it
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- lorenzo.antonuzzo@unifi.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
- Humanitas Mirasole S.p.A.
- Department Name
- Operative unit 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
Spain
- Earliest CTIS Part Ii Submission Date
- 19-06-2025
- Latest Decision Or Authorization Date
- 30-07-2025
- Processing Time Days
- 41
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology
- 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
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Valladares Ayerbes
- Principal Investigator Email
- mvalaye@icloud.com
- Contact Person Name
- Manuel Valladares Ayerbes
- Contact Person Email
- mvalaye@icloud.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Oncology
- Principal Investigator Name
- Maria Rosario Vidal Tocino
- Principal Investigator Email
- mrvidal@saludcastillayleon.es
- Contact Person Name
- Maria Rosario Vidal Tocino
- Contact Person Email
- mrvidal@saludcastillayleon.es
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-12-2025
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 69
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Oncology
- Principal Investigator Name
- Nathalie Marchal
- Principal Investigator Email
- nathalie.marchal@chu.ulg.ac.be
- Contact Person Name
- Nathalie Marchal
- Contact Person Email
- nathalie.marchal@chu.ulg.ac.be
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Principal Investigator Name
- Gertjan Rasschaert
- Principal Investigator Email
- gertjan.rasschaert@uzleuven.be
- Contact Person Name
- Gertjan Rasschaert
- Contact Person Email
- gertjan.rasschaert@uzleuven.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Principal Investigator Name
- Marc Van den Eynde
- Principal Investigator Email
- marc.vandeneynde@saintluc.uclouvain.be
- Contact Person Name
- Marc Van den Eynde
- Contact Person Email
- marc.vandeneynde@saintluc.uclouvain.be
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- 14;3
- Name
- Clario Medical Imaging Inc.
- Responsibilities
- 7
- Name
- Medidata Solutions Inc.
- Responsibilities
- 7
- Name
- Veeva Systems Inc.
- Responsibilities
- 7
- Name
- WCG Clinical Inc.
- Responsibilities
- Safety Monitoring;8
Third parties
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Massive Bio Inc.","duties_or_roles":"Patient recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"14;3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Safety Monitoring;8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Sequencing Solutions Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patients' costs reimbursement","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Telisotuzumab adizutecan (ABBV-400)
- Active Substance
- TELISOTUZUMAB ADIZUTECAN
- Modality
- ADC
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Authorised
- Combination Treatment
- Yes
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