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

NCT06710132 · EMD Serono
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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)
About this study
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.
Eligibility criteria
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 design
Enrollment target: 250 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-29
Estimated completion: 2027-12-23
Last updated: 2026-04-02
Interventions
Drug: M9140
Primary outcomes
  • 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 from first study treatment to (planned) final assessment at approximately 48 months)
Sponsor
EMD Serono Research & Development Institute, Inc. · industry
With: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Merck KGaA, Darmstadt, Germany
Contacts & investigators
ContactCommunication Center · contact · service@emdgroup.com · +496151725200
InvestigatorMedical Responsible · study_director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
All locations (82)
University of California - Los Angeles - 300208353Recruiting
Santa Monica, California, United States
Providence Medical FoundationRecruiting
Santa Rosa, California, United States
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847Active Not Recruiting
Washington D.C., District of Columbia, United States
D&H Cancer Research CenterRecruiting
Margate, Florida, United States
Memorial Cancer Institute at Memorial Healthcare SystemRecruiting
Pembroke Pines, Florida, United States
Prisma Health Cancer Institute, ITOR, CRURecruiting
Greenville, South Carolina, United States
Baptist Cancer CenterRecruiting
Memphis, Tennessee, United States
Baptist Memorial Health Care -MemphisRecruiting
Memphis, Tennessee, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of Texas M. D. Anderson Cancer Center - PartnerRecruiting
Houston, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States
Flinders Medical CentreRecruiting
Bedford Park, Australia
Nepean Cancer Care CentreRecruiting
Kingswood, Australia
Mater Misericordiae Ltd - PARENTRecruiting
South Brisbane, Australia
Macquarie University Hospital - PARENTRecruiting
Sydney, Australia
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - PneumologyRecruiting
Linz, Austria
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und OnkologieRecruiting
Salzburg, Austria
Medical University of Vienna - Department of Internal MedicineRecruiting
Vienna, Austria
Anhui Provincial Cancer HospitalRecruiting
Hefei, Anhui, China
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, Guangzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hebei, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
Xiangya Hospital, Central South UniversityRecruiting
Changsha, Hu'nan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & TechnologyRecruiting
Wuhan, Hubei, China
Sichuan Cancer HospitalRecruiting
Chengdu, Sichuan, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology SurgeryRecruiting
Hangzhou, Zhejiang, China
Institut Bergonié - Service d'Oncologie MédicaleRecruiting
Bordeaux, France
Centre Georges François Leclerc - Unité de Phase IRecruiting
Dijon, France
Centre Oscar Lambret - cancerologie generaleRecruiting
Lille, France
Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur PoumonRecruiting
Lille, France
Hôpital Européen Georges Pompidou - Hématologie OncologieRecruiting
Paris, France
Hôpital Saint-Antoine - Oncologie MédicaleRecruiting
Paris, France
ICO - Site René Gauducheau - Service d'Oncologie medicaleRecruiting
Saint-Herblain, France
Hôpital Foch - Service d'Oncologie MédicaleRecruiting
Suresnes, France
Hopital Rangueil - Service d'Oncologie médicaleRecruiting
Toulouse, France
Institut Claudius Regaud - Service d'oncologie médicaleRecruiting
Toulouse, France
Institut Gustave Roussy - Pathologie ThoraciqueRecruiting
Villejuif, France
Krankenhaus Nordwest GmbH - Neurologische KlinikRecruiting
Frankfurt am Main, Hesse, Germany
St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und PalliativmedizinRecruiting
Bochum, North Rhine-Westphalia, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.Recruiting
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik IRecruiting
Dresden, Saxony, Germany
Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)Recruiting
Leipzig, Saxony, Germany
Charité - Campus Charité Mitte - Charité Comprehensive Cancer CenterRecruiting
Berlin, Germany
Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica BRecruiting
Rome, Roma, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia MedicaRecruiting
Ancona, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Milan, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia FalckRecruiting
Milan, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di OncologiaRecruiting
Reggio Emilia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze MedicheRecruiting
Roma, Italy
National Cancer Center HospitalRecruiting
Chūōku, Japan
Nara Medical University Hospital - Dept of OncologyRecruiting
Kashihara-shi, Japan
Cancer Institute Hospital of JFCRRecruiting
Kōtoku, Japan
Saiseikai Kumamoto Hospital - 300175708Recruiting
Kumamoto, Japan
Kurume University HospitalRecruiting
Kurume-shi, Japan
Niigata Cancer Center Hospital - 300176282Recruiting
Niigata, Japan
Kindai University HospitalRecruiting
Osakasayama-shi, Japan
NHO Hokkaido Cancer Center - 300175802Recruiting
Sapporo, Japan
Chonnam National University Hwasun HospitalRecruiting
Hwasun-gun, Jeollanam-do, South Korea
Pusan National University HospitalRecruiting
Busan, South Korea
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Korea University Guro HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System - Division of Infectious DiseasesRecruiting
Seoul, South Korea
Hospital Universitario Reina Sofia - Dept of OncologyRecruiting
Córdoba, Córdoba, Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia MedicaRecruiting
Badalona, Spain
Hospital Universitari Vall d'Hebron - Oncology Dept.Recruiting
Barcelona, Spain
Hospital Clinic de Barcelona - Servicio de OncologiaRecruiting
Barcelona, Spain
Hospital HM Nou Delfos - START BarcelonaRecruiting
Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de OncologiaRecruiting
L'Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia MedicaRecruiting
Madrid, Spain
Centro Integral Oncologico Clara Campal - Unidad de Fase I-OncologicaRecruiting
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase IRecruiting
Madrid, Spain
Hospital Universitario Ramon y Cajal - Servicio de OncologiaRecruiting
Madrid, Spain
NEXT Madrid - Hospital Universitario Quironsalud MadridRecruiting
Pozuelo de Alarcón, Spain
Hospital Universitario Virgen Macarena - Oncology ServiceRecruiting
Seville, Spain
Hospital Universitario Virgen de ValmeRecruiting
Seville, Spain
Hospital Universitari i Politecnic La Fe - Oncology DepartmentRecruiting
Valencia, Spain
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) · TrialPath