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New drug targets Hard-to-Treat cancers in early trial

NCT ID NCT06710132

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests an experimental drug called M9140 in people with advanced solid tumors (gastric, lung, or pancreatic cancer) that have a specific protein (CEACAM5). The drug is designed to deliver a toxin directly to cancer cells. About 250 adults will receive the drug alone or with other treatments to see if it shrinks tumors and is safe. This is an early-phase trial, so the main goals are to find the right dose and check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

184 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma malignant pancreatic neoplasm non-small cell lung carcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer Non-small cell lung cancer (NSCLC) Pancreatic cancer Pancreatic ductal adenocarcinoma (PDAC) Solid tumors

Contacts and locations

Locations

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230088, China

  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di Oncologia

    Reggio Emilia, Italy

  • Asan Medical Center

    Seoul, South Korea

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica

    Ancona, 60100, Italy

  • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

    Pisa, 56126, Italy

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck

    Milan, 20162, Italy

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Cancer Institute Hospital of JFCR

    Kōtoku, Japan

  • Centre Georges François Leclerc - Unité de Phase I

    Dijon, France

  • Centre Oscar Lambret - cancerologie generale

    Lille, France

  • Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica

    Madrid, Spain

  • Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center

    Berlin, 10117, Germany

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128, South Korea

  • D&H Cancer Research Center

    Margate, Florida, 33063, United States

  • Flinders Medical Centre

    Bedford Park, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche

    Roma, Italy

  • Georgetown University - Lombardi Comprehensive Cancer Center - 1134847

    Washington D.C., District of Columbia, 20007, United States

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon

    Lille, France

  • Hospital Clinic de Barcelona - Servicio de Oncologia

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

    Madrid, 28007, Spain

  • Hospital HM Nou Delfos - START Barcelona

    Barcelona, Spain

  • Hospital Universitari Vall d'Hebron - Oncology Dept.

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe - Oncology Department

    Valencia, 46026, Spain

  • Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid, Spain

  • Hospital Universitario Reina Sofia - Dept of Oncology

    Córdoba, Córdoba, 14004, Spain

  • Hospital Universitario Virgen Macarena - Oncology Service

    Seville, 41009, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41014, Spain

  • Hôpital Européen Georges Pompidou - Hématologie Oncologie

    Paris, France

  • Hôpital Foch - Service d'Oncologie Médicale

    Suresnes, France

  • Hôpital Saint-Antoine - Oncologie Médicale

    Paris, France

  • ICO - Site René Gauducheau - Service d'Oncologie medicale

    Saint-Herblain, France

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica

    Badalona, Spain

  • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

    L'Hospitalet de Llobregat, Spain

  • IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi

    Padova, 35128, Italy

  • Institut Bergonié - Service d'Oncologie Médicale

    Bordeaux, France

  • Institut Claudius Regaud - Service d'oncologie médicale

    Toulouse, France

  • Institut Gustave Roussy - Pathologie Thoracique

    Villejuif, France

  • Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B

    Rome, Roma, 00144, Italy

  • Kindai University Hospital

    Osakasayama-shi, Japan

  • Korea University Guro Hospital

    Seoul, South Korea

  • Krankenhaus Nordwest GmbH - Neurologische Klinik

    Frankfurt am Main, Hesse, 60488, Germany

  • Kurume University Hospital

    Kurume-shi, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, South Korea

  • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie

    Salzburg, Austria

  • Macquarie University Hospital - PARENT

    Sydney, Australia

  • Mater Misericordiae Ltd - PARENT

    South Brisbane, Australia

  • Medical University of Vienna - Department of Internal Medicine

    Vienna, 1090, Austria

  • NEXT Madrid - Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Spain

  • NEXT Virginia

    Fairfax, Virginia, 22031, United States

  • NHO Hokkaido Cancer Center - 300175802

    Sapporo, Japan

  • Nara Medical University Hospital - Dept of Oncology

    Kashihara-shi, Japan

  • National Cancer Center Hospital

    Chūōku, Japan

  • Nepean Cancer Care Centre

    Kingswood, Australia

  • Niigata Cancer Center Hospital - 300176282

    Niigata, Japan

  • Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology

    Linz, Austria

  • Prisma Health Cancer Institute, ITOR, CRU

    Greenville, South Carolina, 29605, United States

  • Providence Medical Foundation

    Santa Rosa, California, 95403, United States

  • Pusan National University Hospital

    Busan, South Korea

  • Saiseikai Kumamoto Hospital - 300175708

    Kumamoto, Japan

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases

    Seoul, South Korea

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610176, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery

    Hangzhou, Zhejiang, 156022, China

  • St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und Palliativmedizin

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangzhou, 510060, China

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430030, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hebei, 430021, China

  • Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)

    Leipzig, Saxony, 04103, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University of California - Los Angeles - 300208353

    Santa Monica, California, 90404, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 611100, China

  • Xiangya Hospital, Central South University

    Changsha, Hu'nan, 410000, China

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