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RECRUITING

NCT06710132

PHASE1/PHASE2

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

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-01-29

Completion Date

2027-12-23

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Solid Tumors Gastric Cancer Non-Small Cell Lung Cancer (NSCLC)Pancreatic Cancer Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

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.

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

Locations (82)

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

Memorial Cancer Institute at Memorial Healthcare System

Pembroke Pines, Florida, United States

Prisma Health Cancer Institute, ITOR, CRU

Greenville, South Carolina, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Baptist Memorial Health Care -Memphis

Memphis, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Texas M. D. Anderson Cancer Center - Partner

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

Hopital Rangueil - Service d'Oncologie médicale

Toulouse, 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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (82)