Clinical trial • Phase I/II • Oncology

PRECEMTABART TOCENTECAN for Advanced gastric cancer | Gastric cancer

Phase I/II trial of PRECEMTABART TOCENTECAN for Advanced gastric cancer | Gastric cancer. open-label, none/not specified-controlled. 73 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced gastric cancer | Gastric 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 Germany, Austria, Italy and others.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True, biomarker: CEACAM5; strata: CEACAM5 high (IHC ≥ 2+ in ≥ 50% of tumor cells) | CEACAM5 low (IHC ≥ 2+ in < 50% of tumor cells)
Target Sample Size
73

Eligibility

Recruits 73 The CTIS record indicates isVulnerablePopulationSelected = true. Inclusion criterion 1: 'Participants are capable of signing informed consent as defined in protocol.' e-Consent is supported (Medable is listed with role 'e-Consent'). Multiple informed consent forms and language versions are provided (documents list DE, FR, ES, IT and EN versions). No mention of assent procedures for minors is provided and participants must be capable of signing consent..

Vulnerable Population
The CTIS record indicates isVulnerablePopulationSelected = true. Inclusion criterion 1: 'Participants are capable of signing informed consent as defined in protocol.' e-Consent is supported (Medable is listed with role 'e-Consent'). Multiple informed consent forms and language versions are provided (documents list DE, FR, ES, IT and EN versions). No mention of assent procedures for minors is provided and participants must be capable of signing consent.

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 in Part A and Part B with documented histopathological diagnosis of advanced or metastatic, HER2 negative, gastric or GEJ adenocarcinoma, 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 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2.\n- Participants in Part A with CEACAM5high GC/GEJC (defined as IHC ≥ 2+ staining in ≥ 50% of tumor cells).\n- Participants in Part B with CEACAM5low GC/GEJC (defined as IHC ≥ 2+ staining in < 50% of tumor cells)."}

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 by Investigators according to 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 AEs and treatment-related AEs as recorded during the study."}
  • {"endpoint_text":"- Duration of Response (DoR) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Measured per RECIST v1.1 as assessed by Investigators."}
  • {"endpoint_text":"- Number of Participants with Disease Control.","definition_or_measurement_approach":"Count of participants achieving disease control as defined in protocol (per investigator assessment)."}
  • {"endpoint_text":"- Time to Response according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Time from treatment initiation to first documented response per RECIST v1.1 by investigators."}
  • {"endpoint_text":"- Progression-free Survival (PFS) according to RECIST v1.1 as assessed by Investigators.","definition_or_measurement_approach":"Time from treatment initiation to disease progression or death per RECIST v1.1 by investigators."}
  • {"endpoint_text":"- Pharmacokinetic (PK) Plasma Concentrations of M9140.","definition_or_measurement_approach":"Serial plasma PK sampling to measure M9140 concentrations (plasma PK assays as described in protocol)."}
  • {"endpoint_text":"- Number of Participants with Anti-Drug Antibodies (ADA) against M9140.","definition_or_measurement_approach":"Assessment of anti-drug antibodies in participant samples (ADA assays)."}
  • {"endpoint_text":"- CEACAM5 expression in tumor.","definition_or_measurement_approach":"Tumor CEACAM5 expression assessed by IHC; used for stratification (IHC ≥2+ in ≥50% or <50% of tumor cells per protocol definitions)."}

Recruitment

Digital Remote Recruitment
True, e-Consent via Medable Inc. is used and electronic patient materials/recruitment content are provided (Medable support available at support@medable.com).
Planned Sample Size
73
Recruitment Window Months
21
Consent Approach
Participants must be capable of signing informed consent per protocol ('Participants are capable of signing informed consent as defined in protocol.'). e-Consent is supported (Medable listed for e-Consent). Multiple language ICFs and country-specific ICF versions are provided (documents include DE, FR, ES, IT and EN versions). No assent or minor-consent procedures are described for children/minors.

Methods

  • Patient Recruitment Outreach by Iuvando Health GmbH (contact: agrawal@iuvando.de) as listed under sponsor third parties.
  • Use of recruitment materials (K1/K2 recruitment arrangements, patient brochures, physician referral letters, study information slides) with country-specific versions (documents available for DE, AT, FR, IT, ES).
  • Site-based recruitment via participating hospitals and university clinics listed in each country (site contacts provided in CTIS record).
  • Patient services to support participation (travel, concierge) provided by Greenphire LLC (contact ctis_inquiry@greenphire.com).
  • Electronic informed consent (e-Consent) provided via Medable Inc. (support@medable.com).

Geography

Total Number Of Sites
36
Total Number Of Participants
45

Germany

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
09-09-2025
Processing Time Days
155
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Universitaet Leipzig
Department Name
UCCL
Contact Person Name
Gertraud Stocker
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung (IKF)
Contact Person Name
Thorsten Oliver Goetze
Contact Person Email
Goetze.Thorsten@khnw.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
I. Medizinische Klinik und Poliklinik
Contact Person Name
Markus Möhler
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
St. Josef Hospital- Med. V- Klinik für Hämatologie und Onkologie mit Palliativmedizin
Contact Person Name
Anke Reinacher-Schick
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Campus Benjamin Franklin ECTU
Contact Person Name
Sebastian Ochsenreither
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Contact Person Name
Gunnar Folprecht

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
3

Sites

Site Name
Medical University Of Vienna
Department Name
Internal Medicine I, Clinical Department for Oncology
Contact Person Name
Gerald Prager
Contact Person Email
gerald.prager@meduniwien.ac.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Internal Medicine III
Contact Person Name
Lukas Weiss
Contact Person Email
lu.weiss@salk.at

Italy

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
23-09-2025
Processing Time Days
196
Number Of Sites
9
Number Of Participants
5

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Internal medicine and medical sciences
Contact Person Name
Gennaro Daniele
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Oncology
Contact Person Name
Fortunato Ciardiello
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
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
Contact Person Name
Lorenza Landi
Contact Person Email
lorenza.landi@ifo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medical Oncology
Contact Person Name
Rossana Berardi
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Oncology
Contact Person Name
Chiara Cremolini
Contact Person Email
chiaracremolini@gmail.com
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Oncology
Contact Person Name
Maria Banzi
Contact Person Email
maria.banzi@ausl.re.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Oncology
Contact Person Name
Salvatore Siena
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology
Contact Person Name
Silvia Damian

Spain

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
212
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncologia
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncologia
Contact Person Name
Federico Longo Muñoz
Contact Person Email
fedelongomunoz@hotmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncologia
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
irene.moreno@startmadrid.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncologia
Contact Person Name
Bernard Gastón Doger
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Institut Catala D'oncologia
Department Name
Oncologia
Contact Person Name
Mariona Calvo Campos
Contact Person Email
mcalvo@iconcologia.net
Site Name
Hospital Germans Trias I Pujol
Department Name
Oncologia
Contact Person Name
Cinta Hierro Carbo
Contact Person Email
chierro@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncologia
Contact Person Name
Maria Vieito Villar
Contact Person Email
mvieito@vhio.net
Site Name
Hospital Clinic De Barcelona
Department Name
Oncologia
Contact Person Name
Ivan Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Hospital Hm Nou Delfos
Department Name
Oncologia
Contact Person Name
Tatiana Hernandez Guerrero
Site Name
Hospital Universitario (additional listed sites)
Department Name
Oncologia

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
18

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
Medical Oncology
Contact Person Name
François GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Hopital Saint Antoine
Department Name
Medical Oncology
Contact Person Name
Romain COHEN
Contact Person Email
romain.cohen@aphp.fr
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Contact Person Name
Antoine HOLLEBECQUE
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology
Contact Person Name
Iphigénie KORAKIS
Site Name
Institut Bergonie
Department Name
Medical Oncology
Contact Person Name
Simon PERNOT
Contact Person Email
s.pernot@bordeaux.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Oncology
Contact Person Name
Julien TAIEB
Contact Person Email
julien.taieb@aphp.fr
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Aurélien CARNOT
Contact Person Email
a-carnot@o-lambret.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Judith RAIMBOURG
Site Name
Hospital Foch
Department Name
Medical Oncology
Contact Person Name
Jaafar BENNOUNA
Contact Person Email
j.bennouna@hopital-foch.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsor duties codes: 1,12,2,6,8 (as listed in CTIS record)
Name
Pharmaceutical Product Development LLC
Responsibilities
PK & ADA sample analysis
Name
CluePoints
Responsibilities
Central Monitoring system
Name
Medable Inc.
Responsibilities
e-Consent
Name
CellCarta
Responsibilities
CEACAM5 IHC Assay
Name
Greenphire LLC
Responsibilities
patient services (transportation, concierge)
Name
Clario Medical Imaging Inc.
Responsibilities
collection and archival of images
Name
Q Squared Solutions Limited
Responsibilities
Central Laboratory Services
Name
Catalent Germany Schorndorf GmbH
Responsibilities
Manage returns and destruction of study drug; labelling
Name
Iuvando Health GmbH
Responsibilities
Patient Recruitment Outreach

Third parties

  • {"country":"Germany","full_name":"Iuvando Health GmbH","duties_or_roles":"Patient Recruitment Outreach","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":"Belgium","full_name":"CellCarta","duties_or_roles":"CEACAM5 IHC Assay","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"e-Consent","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":"Belgium","full_name":"CluePoints","duties_or_roles":"Central Monitoring system","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsor duties code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsor duties codes: 1,12,2,6,8","organisation_type":"Pharmaceutical company"}
  • {"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"}

Investigational products

Investigational Product Name
M9140
Active Substance
PRECEMTABART TOCENTECAN
Modality
ADC
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
1
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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