Clinical trial • Phase I/II • Oncology

PRECEMTABART TOCENTECAN for Non-small cell lung cancer

Phase I/II trial of PRECEMTABART TOCENTECAN for Non-small cell lung cancer. open-label, none/not specified-controlled. 39 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase I/II
Drug Modality
ADC

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, CEACAM5 expression (CEACAM5high) and EGFR mutation status
Target Sample Size
39

Eligibility

Recruits 39 The trial record indicates a vulnerable population is selected (isVulnerablePopulationSelected = true). Inclusion criterion: "Participants are capable of signing informed consent as defined in protocol." The available CTIS metadata lists subject information and ICF documents by country/language, but no explicit assent procedures or further details on consent for minors or other vulnerable groups are provided in the JSON..

Vulnerable Population
The trial record indicates a vulnerable population is selected (isVulnerablePopulationSelected = true). Inclusion criterion: "Participants are capable of signing informed consent as defined in protocol." The available CTIS metadata lists subject information and ICF documents by country/language, but no explicit assent procedures or further details on consent for minors or other vulnerable groups are provided in the JSON.

Inclusion criteria

  • {"criterion_text":"- Participants are capable of signing informed consent as defined in protocol.\n- Participants in Part B with CEACAM5high known EGFR mutated tumors as assessed according to local clinical practice.\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 in Part A and Part B with histologically or cytologically documented advanced (Stage III not eligible for resection or curative radiation) or metastatic NSCLC with or without driver genomic alterations.\n- Participants must have been 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 1 line of therapy for the treatment of advanced/metastatic disease but no more than 3.\n- Participants who received a platinum-containing regimen or a targeted therapy as (neo)-adjuvant therapy for early-stage disease, if relapse or metastases occurred during or within 3 months after regimen completion, are considered to have received a line of treatment in the advanced setting.\n- Participants in Part A with CEACAM5high-expressing EGFR tumors (including participants with any driver genomic alterations other than EGFR mutations)."}

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).\n- Participants with prior therapy with irinotecan."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Objective Response (OR) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Assessed according to RECIST v1.1 by Investigators (Objective Response rate 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 of participants experiencing adverse events and treatment-related adverse events (no further measurement detail provided)."}
  • {"endpoint_text":"- Duration of Response (DoR) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Measured according to RECIST v1.1 by Investigators (time from response to progression or death)."}
  • {"endpoint_text":"- Number of Participants with Disease Control.","definition_or_measurement_approach":"Count of participants achieving disease control (no additional definition provided in JSON)."}
  • {"endpoint_text":"- Time to Response according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Measured according to RECIST v1.1 by Investigators (time from treatment start to first documented response)."}
  • {"endpoint_text":"- Progression-free Survival (PFS) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Measured according to RECIST v1.1 by Investigators (time from treatment start to progression or death)."}
  • {"endpoint_text":"- Pharmacokinetic (PK) Plasma Concentrations of M9140.","definition_or_measurement_approach":"Serial plasma PK concentration measurements of M9140 (no further sampling schedule provided in JSON)."}
  • {"endpoint_text":"- Number of Participants with Anti-Drug Antibodies (ADA) against M9140.","definition_or_measurement_approach":"Assessment of presence of anti-drug antibodies against M9140 (no assay details provided in JSON)."}

Recruitment

Digital Remote Recruitment
True, e-Consent via Medable Inc. is listed and patient-facing digital/payment services (Greenphire ClinCard, bank transfer FAQ) are included in patient materials.
Planned Sample Size
39
Recruitment Window Months
32
Consent Approach
Participants must be capable of signing informed consent as defined in the protocol. Country-specific ICFs and subject information materials are provided (documents indicate Italian, German, French, Spanish and English versions among files). An e-Consent option is listed (Medable Inc.). No specific assent procedures for minors are described in the JSON.

Methods

  • Patient brochures and recruitment materials (country/language-specific K1/K2 recruitment documents listed in CTIS document list).
  • Physician referral letters and study information slides (documented in recruitment materials).
  • Patient services (transportation, concierge) provided by Greenphire LLC (listed as sponsor duty: patient services (transportation, concierge)).
  • Patient Recruitment Outreach performed by Iuvando Health GmbH (listed duty: Patient Recruitment Outreach).
  • Central laboratory services and sample handling via Q Squared Solutions Limited and CellCarta (central lab and assay duties listed).
  • e-Consent and electronic study tools provided by Medable Inc.

Geography

Total Number Of Sites
51
Total Number Of Participants
51

Italy

Earliest CTIS Part Ii Submission Date
13-03-2025
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
187
Number Of Sites
10
Number Of Participants
10

Sites

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
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
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
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
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
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
Istituto Oncologico Veneto
Department Name
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
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
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
Istituto Oncologico Veneto (additional entry)
Department Name
Oncology
Contact Person Name
Placeholder

Austria

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
19-09-2025
Processing Time Days
165
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Abteilung für Pneumologie
Principal Investigator Name
Michael Schumacher
Principal Investigator Email
michael.schumacher@ordensklinikum.at
Contact Person Name
Michael Schumacher
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
14-04-2025
Latest Decision Or Authorization Date
15-09-2025
Processing Time Days
154
Number Of Sites
5
Number Of Participants
5

Sites

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
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
Site Name
Universitaet Leipzig
Department Name
UCCL
Principal Investigator Name
Gertraud Stocker
Contact Person Name
Gertraud Stocker
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
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

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
18
Number Of Participants
18

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Isidoro Carlos Barneto Aranda
Principal Investigator Email
isidoroc.barneto.sspa@juntadeandalucia.es
Contact Person Name
Isidoro Carlos Barneto Aranda
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
Site Name
Institut Catala D'oncologia
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 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 Universitario Virgen De La Macarena
Department Name
Oncology
Principal Investigator Name
Teresa Garcia Manrique
Principal Investigator Email
tgarciamanrique.onco@gmail.com
Contact Person Name
Teresa Garcia Manrique
Contact Person Email
tgarciamanrique.onco@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Rosa Alvarez Alvarez
Principal Investigator Email
rosa.alvarez.al@gmail.com
Contact Person Name
Rosa Alvarez Alvarez
Contact Person Email
rosa.alvarez.al@gmail.com
Site Name
Hospital Universitario Virgen De Valme
Department Name
Oncology
Principal Investigator Name
Jose Fuentes Pradera
Principal Investigator Email
fuentespradera@htmail.com
Contact Person Name
Jose Fuentes Pradera
Contact Person Email
fuentespradera@htmail.com
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 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
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Principal Investigator Name
Oscar José Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar José Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Principal Investigator Name
Iván Victoria Ruiz
Principal Investigator Email
ivictori@recerca.clinic.cat
Contact Person Name
Iván Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
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 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
Hospital Universitario Virgen De La Macarena (additional entry)
Department Name
Oncology
Contact Person Name
Placeholder
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 (duplicate entry)
Contact Person Email
chierro@iconcologia.net
Site Name
Hospital Hm Nou Delfos (duplicate entry)
Department Name
Oncology
Principal Investigator Name
Tatiana Hernandez Guerrero
Principal Investigator Email
tatiana.hernandez@start-barcelona.com
Contact Person Name
Tatiana Hernandez Guerrero

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
16
Number Of Participants
16

Sites

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
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
Site Name
Hospital Foch
Department Name
Medical Oncology
Principal Investigator Name
Jaafar BENNOUNA
Principal Investigator Email
j.bennouna@hopital-foch.com
Contact Person Name
Jaafar BENNOUNA
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pneumology and thoracic oncology
Principal Investigator Name
Simon BALDACCI
Principal Investigator Email
simon.baldacci@chu-lille.fr
Contact Person Name
Simon BALDACCI
Contact Person Email
simon.baldacci@chu-lille.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
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
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
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
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
Institut De Cancerologie De L Ouest (duplicate entry)
Department Name
Medical Oncology
Principal Investigator Name
Judith RAIMBOURG
Principal Investigator Email
judith.raimbourg@ico.unicancer.fr
Contact Person Name
Judith RAIMBOURG
Site Name
Institut Gustave Roussy (duplicate entry)
Department Name
Medical Oncology
Principal Investigator Name
Antoine HOLLEBECQUE
Principal Investigator Email
antoine.hollebecque@gustaveroussy.fr
Contact Person Name
Antoine HOLLEBECQUE
Site Name
Hospital Foch (duplicate entry)
Department Name
Medical Oncology
Principal Investigator Name
Jaafar BENNOUNA
Principal Investigator Email
j.bennouna@hopital-foch.com
Contact Person Name
Jaafar BENNOUNA
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Centre Hospitalier Universitaire De Lille (duplicate entry)
Department Name
Pneumology and thoracic oncology
Principal Investigator Name
Simon BALDACCI
Principal Investigator Email
simon.baldacci@chu-lille.fr
Contact Person Name
Simon BALDACCI
Contact Person Email
simon.baldacci@chu-lille.fr
Site Name
Hopital Saint Antoine (duplicate entry)
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
Oncopole Claudius Regaud (duplicate entry)
Department Name
Medical Oncology
Principal Investigator Name
Iphigénie KORAKIS
Principal Investigator Email
korakis.iphigenie@iuct-oncopole.fr
Contact Person Name
Iphigénie KORAKIS
Site Name
Centr Georges Francois Leclerc (duplicate entry)
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

Sponsor

Primary sponsor

Full Name
Merck Healthcare KGaA
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Pharmaceutical Product Development LLC
Responsibilities
PK & ADA sample analysis
Name
IQVIA Limited
Responsibilities
Multiple clinical operations responsibilities (codes 1,12,2,6,8 listed; specific descriptions not provided in JSON)

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"patient services (transportation, concierge)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7 (duty code provided, description not in JSON)","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":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK & ADA sample analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Iuvando Health GmbH","duties_or_roles":"Patient Recruitment Outreach","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"multiple duties (codes present: 1,12,2,6,8) - specific role descriptions not provided in JSON","organisation_type":"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 States","full_name":"Medable Inc.","duties_or_roles":"e-Consent; additional eClinical duties","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Central Monitoring system","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"collection and archival of images","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"CEACAM5 IHC Assay","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
M9140
Active Substance
PRECEMTABART TOCENTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Frequency
Every 3 weeks (q3w)

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