RecruitingPhase 1Phase 2NCT06710132

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

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)

Sponsor

EMD Serono Research & Development Institute, Inc.

Enrollment

250 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Solid Tumors

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of drug called an antibody-drug conjugate (M9140), which delivers chemotherapy directly to cancer cells that carry a protein called CEACAM5. It is being studied in people with advanced solid tumors, including stomach and gastro-esophageal junction cancers. **You may be eligible if...** - You are able to give informed consent - You are in reasonable overall health (able to care for yourself with minimal assistance) - Your kidneys, liver, and blood counts are within acceptable ranges - You have at least one measurable tumor on scans - For the stomach cancer sub-study: you have HER2-negative advanced stomach or gastro-esophageal junction cancer that has worsened despite prior treatments **You may NOT be eligible if...** - Your general health or organ function does not meet study requirements - Your cancer does not have a measurable lesion on imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGM9140

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.

Locations(81)

University of California - Los Angeles - 300208353

Santa Monica, California, United States

Providence Medical Foundation

Santa Rosa, California, United States

Georgetown University - Lombardi Comprehensive Cancer Center - 1134847

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

D&H Cancer Research Center

Margate, Florida, United States

Prisma Health Cancer Institute, ITOR, CRU

Greenville, South Carolina, United States

Baptist Cancer Center

Memphis, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Flinders Medical Centre

Bedford Park, Australia

Nepean Cancer Care Centre

Kingswood, Australia

Mater Misericordiae Ltd - PARENT

South Brisbane, Australia

Macquarie University Hospital - PARENT

Sydney, Australia

Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology

Linz, Austria

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

Salzburg, Austria

Medical University of Vienna - Department of Internal Medicine

Vienna, Austria

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangzhou, China

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

Wuhan, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Xiangya Hospital, Central South University

Changsha, Hu'nan, China

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

Wuhan, Hubei, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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

Hangzhou, Zhejiang, China

Institut Bergonié - Service d'Oncologie Médicale

Bordeaux, France

Centre Georges François Leclerc - Unité de Phase I

Dijon, France

Centre Oscar Lambret - cancerologie generale

Lille, France

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

Lille, France

Hôpital Européen Georges Pompidou - Hématologie Oncologie

Paris, France

Hôpital Saint-Antoine - Oncologie Médicale

Paris, France

ICO - Site René Gauducheau - Service d'Oncologie medicale

Saint-Herblain, France

Hôpital Foch - Service d'Oncologie Médicale

Suresnes, France

Institut Claudius Regaud - Service d'oncologie médicale

Toulouse, France

Institut Gustave Roussy - Pathologie Thoracique

Villejuif, France

Krankenhaus Nordwest GmbH - Neurologische Klinik

Frankfurt am Main, Hesse, Germany

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

Bochum, North Rhine-Westphalia, Germany

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

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

Dresden, Saxony, Germany

Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)

Leipzig, Saxony, Germany

Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center

Berlin, Germany

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

Rome, Roma, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica

Ancona, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

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

Milan, Italy

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

Naples, Italy

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

Padova, Italy

Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

Pisa, Italy

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

Reggio Emilia, Italy

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

Roma, Italy

National Cancer Center Hospital

Chūōku, Japan

Nara Medical University Hospital - Dept of Oncology

Kashihara-shi, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Saiseikai Kumamoto Hospital - 300175708

Kumamoto, Japan

Kurume University Hospital

Kurume-shi, Japan

Niigata Cancer Center Hospital - 300176282

Niigata, Japan

Kindai University Hospital

Osakasayama-shi, Japan

NHO Hokkaido Cancer Center - 300175802

Sapporo, Japan

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, South Korea

Pusan National University Hospital

Busan, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Seoul, South Korea

Hospital Universitario Reina Sofia - Dept of Oncology

Córdoba, CÃ³rdoba, Spain

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

Badalona, Spain

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, Spain

Hospital Clinic de Barcelona - Servicio de Oncologia

Barcelona, Spain

Hospital HM Nou Delfos - START Barcelona

Barcelona, Spain

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

L'Hospitalet de Llobregat, Spain

Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

Madrid, Spain

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

Madrid, Spain

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

Madrid, Spain

Hospital Universitario Ramon y Cajal - Servicio de Oncologia

Madrid, Spain

NEXT Madrid - Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Spain

Hospital Universitario Virgen Macarena - Oncology Service

Seville, Spain

Hospital Universitario Virgen de Valme

Seville, Spain

Hospital Universitari i Politecnic La Fe - Oncology Department

Valencia, Spain

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NCT06710132

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