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Набира участници Фаза 1/2 NCT06710132

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

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Solid Tumors Gastric Cancer Non-Small Cell Lung Cancer (NSCLC) Pancreatic Cancer Pancreatic Ductal Adenocarcinoma (PDAC)

Спонсор: EMD Serono Research & Development Institute, Inc.

Налично на: БГ
Обобщение
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).
Описание
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.
Кой може да участва
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
Интервенции
M9140
DRUG
Места на провеждане 82
Австралия (4)
Flinders Medical Centre
Bedford Park
Nepean Cancer Care Centre
Kingswood
Mater Misericordiae Ltd - PARENT
South Brisbane
Macquarie University Hospital - PARENT
Sydney
Австрия (3)
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology
Linz
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg
Medical University of Vienna - Department of Internal Medicine
Vienna
Китай (10)
Beijing Cancer Hospital
Beijing , Beijing Municipality
Xiangya Hospital, Central South University
Changsha , Hu'nan
Sichuan Cancer Hospital
Chengdu , Sichuan
West China Hospital, Sichuan University
Chengdu , Sichuan
Sun Yat-sen University Cancer Center
Guangzhou , Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery
Hangzhou , Zhejiang
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
Anhui Provincial Cancer Hospital
Hefei , Anhui
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan , Hebei
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan , Hubei
Франция (11)
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux
Centre Georges François Leclerc - Unité de Phase I
Dijon
Centre Oscar Lambret - cancerologie generale
Lille
Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon
Lille
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris
Hôpital Saint-Antoine - Oncologie Médicale
Paris
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain
Hôpital Foch - Service d'Oncologie Médicale
Suresnes
Hopital Rangueil - Service d'Oncologie médicale
Toulouse
Institut Claudius Regaud - Service d'oncologie médicale
Toulouse
Institut Gustave Roussy - Pathologie Thoracique
Villejuif
Германия (6)
Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center
Berlin
St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und Palliativmedizin
Bochum , North Rhine-Westphalia
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden , Saxony
Krankenhaus Nordwest GmbH - Neurologische Klinik
Frankfurt am Main , Hesse
Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)
Leipzig , Saxony
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.
Mainz , Rhineland-Palatinate
Италия (6)
Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica
Ancona
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck
Milan
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di Oncologia
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
Roma
Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B
Rome , Roma
Япония (8)
National Cancer Center Hospital
Chūōku
Nara Medical University Hospital - Dept of Oncology
Kashihara-shi
Cancer Institute Hospital of JFCR
Kōtoku
Saiseikai Kumamoto Hospital - 300175708
Kumamoto
Kurume University Hospital
Kurume-shi
Niigata Cancer Center Hospital - 300176282
Niigata
Kindai University Hospital
Osakasayama-shi
NHO Hokkaido Cancer Center - 300175802
Sapporo
Южна Корея (9)
Pusan National University Hospital
Busan
Kyungpook National University Chilgok Hospital
Daegu
Chonnam National University Hwasun Hospital
Hwasun-gun , Jeollanam-do
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul
Испания (14)
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona
Hospital HM Nou Delfos - START Barcelona
Barcelona
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba , Córdoba
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón
Hospital Universitario Virgen Macarena - Oncology Service
Seville
Hospital Universitario Virgen de Valme
Seville
Hospital Universitari i Politecnic La Fe - Oncology Department
Valencia
САЩ (11)
NEXT Virginia
Fairfax , Virginia
Prisma Health Cancer Institute, ITOR, CRU
Greenville , South Carolina
The University of Texas MD Anderson Cancer Center
Houston , Texas
University of Texas M. D. Anderson Cancer Center - Partner
Houston , Texas
D&H Cancer Research Center
Margate , Florida
Baptist Cancer Center
Memphis , Tennessee
Baptist Memorial Health Care -Memphis
Memphis , Tennessee
Memorial Cancer Institute at Memorial Healthcare System
Pembroke Pines , Florida
University of California - Los Angeles - 300208353
Santa Monica , California
Providence Medical Foundation
Santa Rosa , California
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
Washington D.C. , District of Columbia
ACTIVE_NOT_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
29.01.2025
Крайна дата
23.12.2027
Регистрационен номер
NCT06710132
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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