Clinical trial • Phase I/II • Oncology
Precemtabart tocentecan for Pancreatic ductal adenocarcinoma | Metastatic pancreatic carcinoma
Phase I/II trial of Precemtabart tocentecan for Pancreatic ductal adenocarcinoma | Metastatic pancreatic carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Pancreatic ductal adenocarcinoma | Metastatic pancreatic carcinoma
- Trial Stage
- Phase I/II
- Drug Modality
- ADC | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-01-2025
- First CTIS Authorization Date
- 05-05-2025
Trial design
open-label, none/not specified-controlled Phase I/II trial in Italy, Austria, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Biomarker Stratified
- True, biomarker: CEACAM5; strata: CEACAM5 high expressing tumors (only CEACAM5 high expressing tumors eligible)
- Target Sample Size
- 22
Eligibility
Recruits 22 The trial metadata flags vulnerable population selection. The protocol requires that "Participants are capable of signing informed consent as defined in protocol." e-Consent is supported (third party Medable Inc. listed with duty "e-Consent"). Country-specific informed consent documents (including pregnancy-specific ICFs) are provided in multiple language versions..
- Vulnerable Population
- The trial metadata flags vulnerable population selection. The protocol requires that "Participants are capable of signing informed consent as defined in protocol." e-Consent is supported (third party Medable Inc. listed with duty "e-Consent"). Country-specific informed consent documents (including pregnancy-specific ICFs) are provided in multiple language versions.
Inclusion criteria
- {"criterion_text":"- Participants are capable of signing informed consent as defined in protocol.\n- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1.\n- Participants with adequate hematologic, hepatic and renal function as defined in protocol.\n- Participant must have at least 1 lesion that is measurable using RECIST v1.1.\n- Participants with histologically or cytologically confirmed advanced or metastatic PDAC, who were intolerant/refractory to or progressed after systemic therapies for the advanced metastatic stage.\n- Participants must have received and progressed (according to RECIST v1.1) on at least one 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2.\n- All participants will be screened using an IHC test to define CEACAM5 expression. Only participants with CEACAM5 high expressing tumors will be eligible."}
Exclusion criteria
- {"criterion_text":"- Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor’s Medical Monitor, is considered cured with minimal risk of recurrence within 3 years).\n- Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).\n- Participants with diarrhea (liquid stool) or ileus Grade > 1.\n- Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s disease, intestinal perforation) and/or bowel obstruction.\n- Cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] ≥ II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 470 milliseconds (ms).\n- Cerebrovascular accident/stroke (< 6 months prior to enrollment)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Objective Response (OR) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Assessed by Investigators using RECIST v1.1 (Objective Response as per RECIST v1.1)."}
Secondary endpoints
- {"endpoint_text":"- Number of Participants with Adverse Events (AEs) and Treatment Related AEs.","definition_or_measurement_approach":"Count and reporting of AEs and treatment-related AEs as per protocol safety assessments."}
- {"endpoint_text":"- Duration of Response (DoR) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Duration measured per RECIST v1.1 criteria as assessed by Investigators."}
- {"endpoint_text":"- Number of Participants with Disease Control.","definition_or_measurement_approach":"Disease control determined per protocol assessments (RECIST v1.1-based disease control at specified timepoints)."}
- {"endpoint_text":"- Time to Response according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Time to first documented response measured using RECIST v1.1."}
- {"endpoint_text":"- Progression-free Survival (PFS) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"PFS assessed using RECIST v1.1 criteria by Investigators."}
- {"endpoint_text":"- Pharmacokinetic (PK) Plasma Concentrations of M9140.","definition_or_measurement_approach":"Plasma concentration measurements of M9140 per PK sampling schedule specified in the protocol."}
- {"endpoint_text":"- Number of Participants with Anti-Drug Antibodies (ADA) against M9140.","definition_or_measurement_approach":"Assessment of ADA presence using immunogenicity assays specified in protocol."}
Recruitment
- Digital Remote Recruitment
- True, e-Consent and digital support: Medable Inc. listed with duty 'e-Consent' to support electronic informed consent; recruitment materials and patient brochures available electronically per country documents.
- Planned Sample Size
- 22
- Recruitment Window Months
- 19
- Consent Approach
- Informed consent must be provided by the participant (protocol: "Participants are capable of signing informed consent as defined in protocol"). e-Consent is supported (Medable Inc. listed with duty 'e-Consent'). Multiple country-specific ICFs and subject information materials are provided (document versions indicate Italian, German/AUT, French, Spanish versions and pregnancy-specific ICFs).
Methods
- Patient brochure and recruitment materials (K2/RecruItMat Patient Brochure documents present for multiple countries) — informational materials for potential participants.
- Patient Recruitment Outreach by Iuvando Health GmbH (third party duty explicitly listed as 'Patient Recruitment Outreach').
- Patient services (transportation, concierge) provided by Greenphire LLC (duty listed: 'patient services (transportation, concierge)').
- Physician referral letters and study information slides (documented recruitment materials, e.g., 'Physician Referral Letter', 'Study Information Slides' referenced in documents).
- Site-based recruitment at participating hospitals/oncology centres (multiple hospital sites listed per country).
Geography
- Total Number Of Sites
- 35
- Total Number Of Participants
- 22
Italy
- Earliest CTIS Part Ii Submission Date
- 13-03-2025
- Latest Decision Or Authorization Date
- 24-09-2025
- Processing Time Days
- 195
- Number Of Sites
- 9
- Number Of Participants
- 3
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Internal medicine and medical sciences
- Principal Investigator Name
- Gennaro Daniele
- Principal Investigator Email
- gennaro.daniele@policlinicogemelli.it
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology
- Principal Investigator Name
- Silvia Damian
- Principal Investigator Email
- silvia.damian@istitutotumori.mi.it
- Contact Person Name
- Silvia Damian
- Contact Person Email
- silvia.damian@istitutotumori.mi.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Medical Oncology
- 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
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lorenza Landi
- Principal Investigator Email
- lorenza.landi@ifo.it
- Contact Person Name
- Lorenza Landi
- Contact Person Email
- lorenza.landi@ifo.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Medical Oncology
- Principal Investigator Name
- Rossana Berardi
- Principal Investigator Email
- rossana.berardi@ospedaliriuniti.marche.it
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- rossana.berardi@ospedaliriuniti.marche.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Banzi
- Principal Investigator Email
- maria.banzi@ausl.re.it
- Contact Person Name
- Maria Banzi
- Contact Person Email
- maria.banzi@ausl.re.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Oncology
- Principal Investigator Name
- Chiara Cremolini
- Principal Investigator Email
- chiaracremolini@gmail.com
- Contact Person Name
- Chiara Cremolini
- Contact Person Email
- chiaracremolini@gmail.com
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Oncology
- Principal Investigator Name
- Salvatore Siena
- Principal Investigator Email
- salvatore.siena@ospedaleniguarda.it
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Oncology
- Principal Investigator Name
- Fortunato Ciardiello
- Principal Investigator Email
- fortunato.ciardiello@unicampania.it
- Contact Person Name
- Fortunato Ciardiello
- Contact Person Email
- fortunato.ciardiello@unicampania.it
Austria
- Earliest CTIS Part Ii Submission Date
- 07-04-2025
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 154
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Internal Medicine III
- 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
- Internal Medicine I, Clinical Department for 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
Germany
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 09-09-2025
- Processing Time Days
- 179
- Number Of Sites
- 6
- Number Of Participants
- 4
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- I. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Markus Möhler
- Principal Investigator Email
- Markus.Moehler@unimedizin-mainz.de
- Contact Person Name
- Markus Möhler
- Contact Person Email
- Markus.Moehler@unimedizin-mainz.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Campus Benjamin Franklin ECTU
- Principal Investigator Name
- Sebastian Ochsenreither
- Principal Investigator Email
- sebastian.ochsenreither@charite.de
- Contact Person Name
- Sebastian Ochsenreither
- Contact Person Email
- sebastian.ochsenreither@charite.de
- Site Name
- Universitaet Leipzig
- Department Name
- UCCL
- Principal Investigator Name
- Gertraud Stocker
- Principal Investigator Email
- stocker.studienmails@medizin.uni-leipzig.de
- Contact Person Name
- Gertraud Stocker
- Contact Person Email
- stocker.studienmails@medizin.uni-leipzig.de
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- St. Josef Hospital- Med. V- Klinik für Hämatologie und Onkologie mit Palliativmedizin
- Principal Investigator Name
- Anke Reinacher-Schick
- Principal Investigator Email
- anke.reinacher-schick@klinikum-bochum.de
- Contact Person Name
- Anke Reinacher-Schick
- Contact Person Email
- anke.reinacher-schick@klinikum-bochum.de
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- Institut für Klinisch-Onkologische Forschung (IKF)
- Principal Investigator Name
- Thorsten Oliver Goetze
- Principal Investigator Email
- Goetze.Thorsten@khnw.de
- Contact Person Name
- Thorsten Oliver Goetze
- Contact Person Email
- Goetze.Thorsten@khnw.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Gunnar Folprecht
- Principal Investigator Email
- gunnar.folprecht@uniklinikum-dresden.de
- Contact Person Name
- Gunnar Folprecht
- Contact Person Email
- gunnar.folprecht@uniklinikum-dresden.de
Spain
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 12-11-2025
- Processing Time Days
- 211
- Number Of Sites
- 9
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Maria Vieito Villar
- Principal Investigator Email
- mvieito@vhio.net
- Contact Person Name
- Maria Vieito Villar
- Contact Person Email
- mvieito@vhio.net
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Principal Investigator Name
- Tatiana Hernandez Guerrero
- Principal Investigator Email
- tatiana.hernandez@start-barcelona.com
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Mariona Calvo Campos
- Principal Investigator Email
- mcalvo@iconcologia.net
- Contact Person Name
- Mariona Calvo Campos
- Contact Person Email
- mcalvo@iconcologia.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Irene Moreno Candilejo
- Principal Investigator Email
- irene.moreno@startmadrid.com
- Contact Person Name
- Irene Moreno Candilejo
- Contact Person Email
- irene.moreno@startmadrid.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Ivan Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Ivan Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Bernard Doger de Speville
- Principal Investigator Email
- Bernard.doger@startmadrid.com
- Contact Person Name
- Bernard Doger de Speville
- Contact Person Email
- Bernard.doger@startmadrid.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Oncology
- Principal Investigator Name
- Cinta Hierro Carbó
- Principal Investigator Email
- chierro@iconcologia.net
- Contact Person Name
- Cinta Hierro Carbó
- Contact Person Email
- chierro@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Federico Longo Muñoz
- Principal Investigator Email
- fedelongomunoz@hotmail.com
- Contact Person Name
- Federico Longo Muñoz
- Contact Person Email
- fedelongomunoz@hotmail.com
France
- Earliest CTIS Part Ii Submission Date
- 04-04-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 262
- Number Of Sites
- 9
- Number Of Participants
- 8
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology
- Principal Investigator Name
- Iphigénie Korakis
- Principal Investigator Email
- korakis.iphigenie@iuct-oncopole.fr
- Contact Person Name
- Iphigénie Korakis
- Contact Person Email
- korakis.iphigenie@iuct-oncopole.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical 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
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Principal Investigator Name
- François Ghiringhelli
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- François Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Medical Oncology
- Principal Investigator Name
- Romain Cohen
- Principal Investigator Email
- romain.cohen@aphp.fr
- Contact Person Name
- Romain Cohen
- Contact Person Email
- romain.cohen@aphp.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Judith Raimbourg
- Principal Investigator Email
- judith.raimbourg@ico.unicancer.fr
- Contact Person Name
- Judith Raimbourg
- Contact Person Email
- judith.raimbourg@ico.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Simon Pernot
- Principal Investigator Email
- s.pernot@bordeaux.unicancer.fr
- Contact Person Name
- Simon Pernot
- Contact Person Email
- s.pernot@bordeaux.unicancer.fr
- Site Name
- Hospital Foch
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jafar Bennouna
- Principal Investigator Email
- j.bennouna@hopital-foch.com
- Contact Person Name
- Jafar Bennouna
- Contact Person Email
- j.bennouna@hopital-foch.com
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology
- Principal Investigator Name
- Aurélien Carnot
- Principal Investigator Email
- a-carnot@o-lambret.fr
- Contact Person Name
- Aurélien Carnot
- Contact Person Email
- a-carnot@o-lambret.fr
Sponsor
Primary sponsor
- Full Name
- Merck Healthcare KGaA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Multiple study support functions (sponsorDuties codes listed; specific text duties not provided in JSON)
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- PK & ADA sample analysis
- Name
- Catalent Germany Schorndorf GmbH
- Responsibilities
- Manage returns and destruction of study drug; labelling
Third parties
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"patient services (transportation, concierge)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Central Laboratory Services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"Manage returns and destruction of study drug; labelling","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK & ADA sample analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"CEACAM5 IHC Assay","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Central Monitoring system","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"e-Consent","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"collection and archival of images","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Iuvando Health GmbH","duties_or_roles":"Patient Recruitment Outreach","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- M9140
- Active Substance
- Precemtabart tocentecan
- Modality
- ADC | Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Starting Dose
- 2.8 mg/kg
- Dose Levels
- 2.8 mg/kg
- Frequency
- Every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles
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