Clinical trial • Phase II • Oncology
TELISOTUZUMAB ADIZUTECAN for Colorectal cancer|Metastatic colorectal cancer
Phase II trial of TELISOTUZUMAB ADIZUTECAN for Colorectal cancer|Metastatic colorectal cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Colorectal cancer|Metastatic colorectal cancer
- Trial Stage
- Phase II
- Drug Modality
- ADC|Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-04-2024
- First CTIS Authorization Date
- 02-08-2024
Trial design
Randomised, fluorouracil (route: intravenous infusion; dose unit reported mg/m2; max daily amount reported 2400 mg/m2), folinic acid (route: intravenous infusion; dose unit mg/m2; max daily amount reported 400 mg/m2), bevacizumab (route: intravenous infusion; dose unit mg/kg; max daily amount reported 5 mg/kg), irinotecan (route: intravenous infusion; dose unit mg/m2; max daily amount reported 400 mg/m2). no detailed schedules provided in the available record.-controlled, adaptive Phase II trial across 21 sites in Spain, Germany, Belgium.
- Randomised
- Yes
- Comparator
- Fluorouracil (route: intravenous infusion; dose unit reported mg/m2; max daily amount reported 2400 mg/m2), Folinic acid (route: intravenous infusion; dose unit mg/m2; max daily amount reported 400 mg/m2), Bevacizumab (route: intravenous infusion; dose unit mg/kg; max daily amount reported 5 mg/kg), Irinotecan (route: intravenous infusion; dose unit mg/m2; max daily amount reported 400 mg/m2). No detailed schedules provided in the available record.
- Adaptive
- Yes
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 145
Eligibility
Recruits 145 Vulnerable population selected. Subject information sheets and multiple Informed Consent Forms (Main, Optional, Pregnant Partner, continued treatment addenda) are provided per country and language (see public ICF documents); no specific text on assent or consent by legal guardians is provided in the available record..
- Vulnerable Population
- Vulnerable population selected. Subject information sheets and multiple Informed Consent Forms (Main, Optional, Pregnant Partner, continued treatment addenda) are provided per country and language (see public ICF documents); no specific text on assent or consent by legal guardians is provided in the available record.
Inclusion criteria
- {"criterion_text":"- Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).\n- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1."}
Exclusion criteria
- {"criterion_text":"- Harbor the BRAF V600E mutation.\n- dMMR+/MSI-H.\n- Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.\n- Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective Response as assessed by the investigator\n- Progression Free Survival (PFS) as assessed by the investigator","definition_or_measurement_approach":"Objective Response: assessed by the investigator (measurable disease per RECIST v1.1 is specified elsewhere). PFS: progression-free survival as assessed by the investigator; no further measurement definitions provided in the available record."}
Secondary endpoints
- {"endpoint_text":"- Duration of Response (DOR) as assessed by the investigator\n- Overall Survival (OS)\n- Best Overall Response (BOR) as assessed by the investigator","definition_or_measurement_approach":"DOR: assessed by the investigator (no further definition provided). OS: overall survival (no further definition provided). BOR: assessed by the investigator (no further definition provided)."}
Recruitment
- Planned Sample Size
- 145
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent is documented via Subject Information Sheets and Informed Consent Forms. Public ICF documents are available per country and language (examples: Spain - Spanish; Germany - German; Belgium - English/Dutch/French). Consent appears to be obtained from adult participants; no details on assent or guardian consent for minors are provided in the available records.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 61
Spain
- Earliest CTIS Part Ii Submission Date
- 19-07-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 580
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncología
- Principal Investigator Name
- Pilar Garcia Alfonso
- Principal Investigator Email
- pgarcaalfonso@gmail.com
- Contact Person Name
- Pilar Garcia Alfonso
- Contact Person Email
- pgarcaalfonso@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Oncología
- Principal Investigator Name
- Andres Cervantes Ruiperez
- Principal Investigator Email
- andres.cervantes@uv.es
- Contact Person Name
- Andres Cervantes Ruiperez
- Contact Person Email
- andres.cervantes@uv.es
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Oncología
- Principal Investigator Name
- Eduardo Polo Marques
- Principal Investigator Email
- eduardopolomarques@hotmail.com
- Contact Person Name
- Eduardo Polo Marques
- Contact Person Email
- eduardopolomarques@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncología
- Principal Investigator Name
- Cristina Gravalos Castro
- Principal Investigator Email
- cristina.gravalos@salud.madrid.org
- Contact Person Name
- Cristina Gravalos Castro
- Contact Person Email
- cristina.gravalos@salud.madrid.org
- 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
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncología
- Principal Investigator Name
- Anotnio Cubillo Gracian
- Principal Investigator Email
- acubillo@hmhospitales.com
- Contact Person Name
- Anotnio Cubillo Gracian
- Contact Person Email
- acubillo@hmhospitales.com
Germany
- Earliest CTIS Part Ii Submission Date
- 19-07-2024
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 581
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik I
- Principal Investigator Name
- Michael Bitzer
- Principal Investigator Email
- IM1CTIS@med.uni-tuebingen.de
- Contact Person Name
- Michael Bitzer
- Contact Person Email
- IM1CTIS@med.uni-tuebingen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Department of Internal Medicine II Oncological Clinical Trials Center
- Principal Investigator Name
- Marianne Sinn
- Principal Investigator Email
- ma.sinn@uke.de
- Contact Person Name
- Marianne Sinn
- Contact Person Email
- ma.sinn@uke.de
- Site Name
- Universitat Heidelberg
- Department Name
- Tagestherapiezentrum Haus 9
- Principal Investigator Name
- Ralf-Dieter Hofheinz
- Principal Investigator Email
- Ralf-Dieter.Hofheinz@medma.uni-heidelberg.de
- Contact Person Name
- Ralf-Dieter Hofheinz
- Contact Person Email
- Ralf-Dieter.Hofheinz@medma.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Thomas Ettrich
- Principal Investigator Email
- Thomas.ettrich@uniklinik-ulm.de
- Contact Person Name
- Thomas Ettrich
- Contact Person Email
- Thomas.ettrich@uniklinik-ulm.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik m.S. Hämatologie, Onkologie und Tumorimmunologie
- Principal Investigator Name
- Dominik Modest
- Principal Investigator Email
- dominik.modest@charite.de
- Contact Person Name
- Dominik Modest
- Contact Person Email
- dominik.modest@charite.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Gunnar Folprecht
- Principal Investigator Email
- oncostudy@ukdd.de
- Contact Person Name
- Gunnar Folprecht
- Contact Person Email
- oncostudy@ukdd.de
- Site Name
- University Medical Center (Mannheim) - listed as Universitat Heidelberg address
- Department Name
- Tagestherapiezentrum Haus 9
- Principal Investigator Name
- Ralf-Dieter Hofheinz
- Principal Investigator Email
- Ralf-Dieter.Hofheinz@medma.uni-heidelberg.de
- Contact Person Name
- Ralf-Dieter Hofheinz
- Contact Person Email
- Ralf-Dieter.Hofheinz@medma.uni-heidelberg.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 18-07-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 581
- Number Of Sites
- 8
- Number Of Participants
- 21
Sites
- Site Name
- Imelda
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Piter-Jan Cuyle
- Principal Investigator Email
- pieter-jan.cuyle@imelda.be
- Contact Person Name
- Piter-Jan Cuyle
- Contact Person Email
- pieter-jan.cuyle@imelda.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Medical Oncology
- Principal Investigator Name
- Marc Van Den Eynde
- Principal Investigator Email
- marc.vandeneynde@uclouvain.be
- Contact Person Name
- Marc Van Den Eynde
- Contact Person Email
- marc.vandeneynde@uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Gastroenterology
- Principal Investigator Name
- Karen Geboes
- Principal Investigator Email
- karen.geboes@uzgent.be
- Contact Person Name
- Karen Geboes
- Contact Person Email
- karen.geboes@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Digestive Oncology
- Principal Investigator Name
- Filip Van Herpe
- Principal Investigator Email
- filip.vanherpe@uzleuven.be
- Contact Person Name
- Filip Van Herpe
- Contact Person Email
- filip.vanherpe@uzleuven.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Sofie De Meulder
- Principal Investigator Email
- sodie.demeulder@azdelta.be
- Contact Person Name
- Sofie De Meulder
- Contact Person Email
- sodie.demeulder@azdelta.be
- Site Name
- Institut Jules Bordet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Francesco Sclafani
- Principal Investigator Email
- francesco.sclafani@hubruxelles.be
- Contact Person Name
- Francesco Sclafani
- Contact Person Email
- francesco.sclafani@hubruxelles.be
- Site Name
- Antwerp University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Additional Belgian site entry (as listed)
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"sponsorDuties: code \"15\"; value: \"Imaging\"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [\"3\"]","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":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [\"7\"]","organisation_type":"Non-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
- Authorised
- Maximum Dose
- 3 mg/kg (max daily); max total amount reported 117 mg/kg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)