Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

April 27, 2026 updated by: EMD Serono Research & Development Institute, Inc.

PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)

The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as monotherapy or in combination treatments in adult participants with locally advanced/metastatic CEACAM5 expressing tumors. There will be 3 substudies under this Master Protocol that may be conducted in parallel.

  • PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Gastric Cancer (Substudy GC);
  • PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer (Substudy NSCLC);
  • PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study follows a master protocol concept with several separate substudies in specific indications.

  • Substudy GC: The study duration per participant is on an average approximately 10 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.
  • Substudy NSCLC: Study duration per participant is approximately 12 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.
  • Substudy PDAC: Study duration per participant is on an average approximately 8 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (±3) days after the last dose of M9140.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Bedford Park, Australia
        • Recruiting
        • Flinders Medical Centre
        • Principal Investigator:
          • Amitesh C Roy
      • Kingswood, Australia
      • South Brisbane, Australia
        • Recruiting
        • Mater Misericordiae Ltd - PARENT
        • Principal Investigator:
          • Vikram K Jain
      • Sydney, Australia
        • Recruiting
        • Macquarie University Hospital - PARENT
        • Principal Investigator:
          • Andrew O Parsonson
  • Austria
      • Linz, Austria
        • Recruiting
        • Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology
        • Principal Investigator:
          • Michael Schumacher
      • Salzburg, Austria
        • Recruiting
        • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
        • Principal Investigator:
          • Lukas Weiss
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna - Department of Internal Medicine
        • Contact:
        • Principal Investigator:
          • Gerald Prager
  • China
    • Anhui
      • Hefei, Anhui, China, 230088
        • Recruiting
        • Anhui Provincial Cancer Hospital
        • Principal Investigator:
          • Yueyin Pan
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital
        • Principal Investigator:
          • Jun Zhao
        • Contact:
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Principal Investigator:
          • Ruihua Xu
        • Contact:
    • Hebei
      • Wuhan, Hebei, China, 430021
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Xiaorong Dong
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Baogang Liu
        • Contact:
    • Hu'nan
      • Changsha, Hu'nan, China, 410000
        • Recruiting
        • Xiangya Hospital, Central South University
        • Principal Investigator:
          • Min Li
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
        • Principal Investigator:
          • Xianglin Yuan
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610176
        • Recruiting
        • Sichuan Cancer Hospital
        • Principal Investigator:
          • Juan Li
        • Contact:
      • Chengdu, Sichuan, China, 611100
    • Zhejiang
      • Hangzhou, Zhejiang, China, 156022
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery
        • Principal Investigator:
          • Yong Fang
        • Contact:
  • France
      • Bordeaux, France
        • Recruiting
        • Institut Bergonié - Service d'Oncologie Médicale
        • Principal Investigator:
          • Simon Pernot
      • Dijon, France
        • Recruiting
        • Centre Georges François Leclerc - Unité de Phase I
        • Principal Investigator:
          • Francois Ghiringhelli
      • Lille, France
        • Recruiting
        • Centre Oscar Lambret - cancerologie generale
        • Principal Investigator:
          • Nicolas Penel
      • Lille, France
        • Recruiting
        • Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon
        • Principal Investigator:
          • Simon Baldacci
      • Paris, France
        • Recruiting
        • Hôpital Européen Georges Pompidou - Hématologie Oncologie
        • Principal Investigator:
          • Julien Taieb
      • Paris, France
        • Recruiting
        • Hôpital Saint-Antoine - Oncologie Médicale
        • Principal Investigator:
          • Romain Cohen
      • Saint-Herblain, France
        • Recruiting
        • ICO - Site René Gauducheau - Service d'Oncologie medicale
        • Principal Investigator:
          • Judith Raimbourg
      • Suresnes, France
        • Recruiting
        • Hôpital Foch - Service d'Oncologie Médicale
        • Principal Investigator:
          • Jaafar Bennouna
      • Toulouse, France
        • Recruiting
        • Institut Claudius Regaud - Service d'oncologie médicale
        • Principal Investigator:
          • Iphigenie Korakis
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy - Pathologie Thoracique
        • Principal Investigator:
          • Cristina Smolenschi
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center
        • Principal Investigator:
          • Sebastian Ochsenreither
        • Contact:
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60488
        • Recruiting
        • Krankenhaus Nordwest GmbH - Neurologische Klinik
        • Contact:
        • Principal Investigator:
          • Thorsten 0 Goetze
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
        • Recruiting
        • St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und Palliativmedizin
        • Principal Investigator:
          • Anke Reinacher-Schick
        • Contact:
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.
        • Principal Investigator:
          • Markus Moehler
        • Contact:
    • Saxony
      • Dresden, Saxony, Germany, 01307
      • Leipzig, Saxony, Germany, 04103
  • Italy
      • Ancona, Italy, 60100
        • Recruiting
        • Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica
        • Principal Investigator:
          • Rossana Berardi
      • Milan, Italy, 20133
      • Milan, Italy, 20162
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck
        • Contact:
        • Principal Investigator:
          • Salvatore Siema
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia
        • Principal Investigator:
          • Fortunato Ciardiello
      • Padova, Italy, 35128
        • Recruiting
        • IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi
        • Principal Investigator:
          • Sara Lonardi
      • Pisa, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II
        • Principal Investigator:
          • Chiara Cremolini
      • Reggio Emilia, Italy
        • Recruiting
        • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di Oncologia
        • Principal Investigator:
          • Maria Banzi
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
        • Principal Investigator:
          • Gennaro Daniele
    • Roma
      • Rome, Roma, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B
        • Contact:
        • Principal Investigator:
          • Lorenza Landi
  • Japan
      • Chūōku, Japan
        • Recruiting
        • National Cancer Center Hospital
        • Principal Investigator:
          • Hidekazu Hirano
      • Kashihara-shi, Japan
        • Recruiting
        • Nara Medical University Hospital - Dept of Oncology
        • Principal Investigator:
          • Masayuki Takeda
      • Kumamoto, Japan
      • Kurume-shi, Japan
        • Recruiting
        • Kurume University Hospital
        • Principal Investigator:
          • Koichi Azuma
      • Kōtoku, Japan
        • Recruiting
        • Cancer Institute Hospital of JFCR
        • Principal Investigator:
          • Shota Fukuoka
      • Niigata, Japan
        • Recruiting
        • Niigata Cancer Center Hospital - 300176282
        • Principal Investigator:
          • Hiroshi Tanaka
      • Osakasayama-shi, Japan
        • Recruiting
        • Kindai University Hospital
        • Principal Investigator:
          • Junko Tanizaki
      • Sapporo, Japan
        • Recruiting
        • NHO Hokkaido Cancer Center - 300175802
        • Principal Investigator:
          • Noriyuki Yamada
  • South Korea
      • Busan, South Korea
        • Recruiting
        • Pusan National University Hospital
        • Principal Investigator:
          • Jung Seop Eom
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Shin Yup Lee
        • Contact:
      • Seongnam, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Keun-Wook Lee
      • Seoul, South Korea
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Do-youn Oh
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Dae Ho Lee
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • Sung Yong Lee
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
        • Principal Investigator:
          • Hye Jin Choi
    • Jeollanam-do
      • Hwasun-gun, Jeollanam-do, South Korea, 58128
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Principal Investigator:
          • Young-Chul Kim
  • Spain
      • Badalona, Spain
        • Recruiting
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
        • Principal Investigator:
          • Cinta Hierro Carbó
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona - Servicio de Oncologia
        • Contact:
        • Principal Investigator:
          • Ivan Manuel Victoria Ruiz
      • Barcelona, Spain
        • Recruiting
        • Hospital HM Nou Delfos - START Barcelona
        • Principal Investigator:
          • Tatiana Hernandez Guerrero
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron - Oncology Dept.
        • Contact:
        • Principal Investigator:
          • Maria Vieito Villar
      • L'Hospitalet de Llobregat, Spain
        • Recruiting
        • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
        • Principal Investigator:
          • Mariona Calvo Campos
      • Madrid, Spain
        • Recruiting
        • Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
        • Principal Investigator:
          • Maria Jose de Miguel Luken
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal - Servicio de Oncologia
        • Principal Investigator:
          • Federico Longo Munoz
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
        • Principal Investigator:
          • Bernard Gaston Doger de Speville Uribe
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
        • Principal Investigator:
          • Rosa Alvarez Alvarez
        • Contact:
      • Pozuelo de Alarcón, Spain
        • Recruiting
        • NEXT Madrid - Hospital Universitario Quironsalud Madrid
        • Principal Investigator:
          • Valentina Boni
      • Seville, Spain, 41014
        • Recruiting
        • Hospital Universitario Virgen de Valme
        • Principal Investigator:
          • Jose Fuentes Pradera
        • Contact:
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena - Oncology Service
        • Contact:
        • Principal Investigator:
          • Teresa Garcia Manrique
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe - Oncology Department
        • Principal Investigator:
          • Oscar Jose Juan Vidal
        • Contact:
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia - Dept of Oncology
        • Principal Investigator:
          • Isidoro Carlos Barneto Aranda
        • Contact:
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • University of California - Los Angeles - 300208353
        • Principal Investigator:
          • Zev A Wainberg
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Ian C Anderson
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Active, not recruiting
        • Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
    • Florida
      • Margate, Florida, United States, 33063
        • Recruiting
        • D&H Cancer Research Center
        • Contact:
        • Principal Investigator:
          • Emilio P Araujo Mino
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute, ITOR, CRU
        • Principal Investigator:
          • William J Edenfield
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Cancer Center
        • Principal Investigator:
          • Osarenren Ogbeide
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Natalie Vokes
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants are capable of signing informed consent as defined in protocol
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
  • Participants with adequate hematologic, hepatic and renal function as defined in protocol
  • Participant must have at least 1 lesion that is measurable using RECIST v1.1.
  • Other protocol defined inclusion criteria could apply

Substudy GC:

  • Participants in Part A and Part B with documented histopathological diagnosis of advanced or metastatic, HER2 negative, gastric or GEJ (with an epicenter 2 centimeter (cm) proximal or distal to the GEJ) adenocarcinoma, who were intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage that must have included (provided there is no medical contraindication and these agents are locally approved and available) a fluoropyrimidine and a platinum agent and an Immune checkpoint inhibitors (ICI) for participants with a known microsatellite instability-high (MSI-H) status or participants whose tumor express PD-L1 with a CPS greater than or equal (>=) 1
  • Participants must have received and progressed (according to RECIST 1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2
  • Participants in Part A with CEACAM5high GC/GEJC (defined as IHC >= 2+ staining in >= 50% of tumor cells)
  • Participants in Part B with CEACAM5low GC/GEJC (defined as IHC >= 2+ staining in less than (<) 50% of tumor cells)
  • Other protocol defined inclusion criteria could apply

Substudy NSCLC:

  • 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
  • Participants must have been intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage
  • Participants must have received and progressed (according to RECIST 1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 3
  • 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
  • Participants in Part A with CEACAM5 high-expressing EGFR tumors (including participants with any driver genomic alterations other than EGFR mutations
  • Participants in Part B with CEACAM5 high known EGFR mutated tumors as assessed according to local clinical practice
  • Other protocol defined inclusion criteria could apply

Substudy PDAC:

  • 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 that must have included (provided there is no medical contraindications, and these agents are locally approved and available; FOLFIRINOX regimen or NALIRIFNOX regimen or Nab-paclitaxel/gemcitabine regimen
  • Participants must have received and progressed (according to RECIST 1.1) on at least one 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2
  • All participants will be screened using an IHC test to define CEACAM5 expression. Only participants with CEACAM5high expressing tumors will be eligible
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • 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)
  • 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)
  • Participants with diarrhea (liquid stool) or ileus Grade > 1
  • Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
  • 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)
  • Cerebrovascular accident/stroke (< 6 months prior to enrollment)
  • Other protocol defined exclusion criteria could apply

Substudy GC - Participants with prior therapy with irinotecan

Substudy NSCLC:

- Participants with prior therapy with irinotecan

Substudy PDAC: none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Substudy GC: M9140 Monotherapy - Part A CEACAM5 High
Drug: M9140
All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
Other Names:
  • Precemtabart tocentecan
Experimental: Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low
Drug: M9140
All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
Other Names:
  • Precemtabart tocentecan
Experimental: Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt
Drug: M9140
All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
Other Names:
  • Precemtabart tocentecan
Experimental: Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut
Drug: M9140
All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
Other Names:
  • Precemtabart tocentecan
Experimental: Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High
Drug: M9140
All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
Other Names:
  • Precemtabart tocentecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Substudies GC/NSCLC/PDAC: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
Time Frame: Time from first study treatment to (planned) final assessment at approximately 48 months
Time from first study treatment to (planned) final assessment at approximately 48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Substudies GC/NSCLC/PDAC: Number of Participants with Adverse Events (AEs) and Treatment Related AEs
Time Frame: Time from first study treatment to (planned) final assessment at approximately 48 months
Time from first study treatment to (planned) final assessment at approximately 48 months
Substudies GC/NSCLC/PDAC: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
Time Frame: Time from first study treatment to (planned) final assessment at approximately 48 months
Time from first study treatment to (planned) final assessment at approximately 48 months
Substudies GC/NSCLC/PDAC: Number of Participants with Disease Control
Time Frame: At Week 12
At Week 12
Substudies GC/NSCLC/PDAC: Time to Response according to RECIST v1.1 as Assessed by Investigators
Time Frame: Time from first study treatment to (planned) final assessment at approximately 48 months
Time from first study treatment to (planned) final assessment at approximately 48 months
Substudies GC/NSCLC/PDAC: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
Time Frame: Time from first study treatment throughout the study duration until progressive disease or death due to any cause, whichever occur first, approximately 48 months
Time from first study treatment throughout the study duration until progressive disease or death due to any cause, whichever occur first, approximately 48 months
Substudies GC/ NSCLC/ PDAC: Pharmacokinetic (PK) Plasma Concentrations of M9140
Time Frame: Cycle (C) 1 Day (D) 1 to C3D15, C4D1 and from C8D1 every 4 cycles on D1 until treatment discontinuation (each cycle is of 21 days), assessed up to approximately 12 months
Cycle (C) 1 Day (D) 1 to C3D15, C4D1 and from C8D1 every 4 cycles on D1 until treatment discontinuation (each cycle is of 21 days), assessed up to approximately 12 months
Substudies GC/NSCLC/PDAC: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140
Time Frame: Predose (C1D1, C3D1, C8D1) and end of study intervention, assessed up to approximately 12 months
Predose (C1D1, C3D1, C8D1) and end of study intervention, assessed up to approximately 12 months
Substudy GC: CEACAM5 expression in tumor
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMD Serono Research & Development Institute, Inc.

Collaborators

Merck KGaA, Darmstadt, Germany
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2025

Primary Completion (Estimated)

December 23, 2027

Study Completion (Estimated)

December 23, 2027

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS202329_0010
  • 2024-517817-34-00 (Other Identifier: CTIS)
  • 2024-517818-15-00 (Other Identifier: CTIS)
  • 2024-517819-74-00 (Other Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

IPD Sharing Time Frame

Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union

IPD Sharing Access Criteria

Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on M9140

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe