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

NCT06710132 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: MS202329_00102024-517817-34-002024-517818-15-002024-517819-74-00
• Study Type: interventional
• Target: 250
• Locations: 9 countries
• Sites: 77

Brief 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).

Conditions

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

Keywords

ADC; TOP1 inhibitor; Gastric Cancer; Gastroesophageal junction cancer; Non-Small Cell Lung Cancer; Pancreatic Cancer; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Substudies GC/NSCLC/PDAC: Number of Participants with Adverse Events (AEs) and Treatment Related AEs

  Time from first study treatment to (planned) final assessment at approximately 48 months

• Substudies GC/NSCLC/PDAC: Duration of Response (DoR) 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

• Substudies GC/NSCLC/PDAC: Number of Participants with Disease Control

  At Week 12

• Substudies GC/NSCLC/PDAC: Time to Response according to RECIST v1.1 as Assessed by Investigators

  Time from first study treatment to (planned) final assessment at approximately 48 months

• Substudies GC/NSCLC/PDAC: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators

  Time from first study treatment throughout the study duration until progressive disease or death due to any cause, whichever occur first, approximately 48 months

Study Arms (5)

Substudy GC: M9140 Monotherapy - Part A CEACAM5 High

EXPERIMENTAL

Drug: M9140

Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low

EXPERIMENTAL

Drug: M9140

Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt

EXPERIMENTAL

Drug: M9140

Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut

EXPERIMENTAL

Drug: M9140

Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High

EXPERIMENTAL

Drug: M9140

Interventions

M9140 DRUG

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.

Also known as: Precemtabart tocentecan

Substudy GC: M9140 Monotherapy - Part A CEACAM5 High; Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low; Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt; Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut; Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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

You may not qualify if:

• 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)
• Substudy GC - Participants with prior therapy with irinotecan
• Substudy NSCLC:
• \- Participants with prior therapy with irinotecan
• Substudy PDAC: none

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: collaborator
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (81)

University of California - Los Angeles - 300208353

Santa Monica, California, 90404, United States

RECRUITING

Providence Medical Foundation

Santa Rosa, California, 95403, United States

RECRUITING

Georgetown University - Lombardi Comprehensive Cancer Center - 1134847

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

ACTIVE NOT RECRUITING

D&H Cancer Research Center

Margate, Florida, 33063, United States

RECRUITING

Prisma Health Cancer Institute, ITOR, CRU

Greenville, South Carolina, 29605, United States

RECRUITING

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Flinders Medical Centre

Bedford Park, Australia

RECRUITING

Nepean Cancer Care Centre

Kingswood, Australia

RECRUITING

Mater Misericordiae Ltd - PARENT

South Brisbane, Australia

RECRUITING

Macquarie University Hospital - PARENT

Sydney, Australia

RECRUITING

Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology

Linz, Austria

RECRUITING

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

Salzburg, Austria

RECRUITING

Medical University of Vienna - Department of Internal Medicine

Vienna, 1090, Austria

RECRUITING

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230088, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangzhou, 510060, China

RECRUITING

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

Wuhan, Hebei, 430021, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, Hu'nan, 410000, China

RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610176, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 611100, China

RECRUITING

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

Hangzhou, Zhejiang, 156022, China

RECRUITING

Institut Bergonié - Service d'Oncologie Médicale

Bordeaux, France

RECRUITING

Centre Georges François Leclerc - Unité de Phase I

Dijon, France

RECRUITING

Centre Oscar Lambret - cancerologie generale

Lille, France

RECRUITING

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

Lille, France

RECRUITING

Hôpital Européen Georges Pompidou - Hématologie Oncologie

Paris, France

RECRUITING

Hôpital Saint-Antoine - Oncologie Médicale

Paris, France

RECRUITING

ICO - Site René Gauducheau - Service d'Oncologie medicale

Saint-Herblain, France

RECRUITING

Hôpital Foch - Service d'Oncologie Médicale

Suresnes, France

RECRUITING

Institut Claudius Regaud - Service d'oncologie médicale

Toulouse, France

RECRUITING

Institut Gustave Roussy - Pathologie Thoracique

Villejuif, France

RECRUITING

Krankenhaus Nordwest GmbH - Neurologische Klinik

Frankfurt am Main, Hesse, 60488, Germany

RECRUITING

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

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

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

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

Dresden, Saxony, 01307, Germany

RECRUITING

Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)

Leipzig, Saxony, 04103, Germany

RECRUITING

Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center

Berlin, 10117, Germany

RECRUITING

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

Rome, Roma, 00144, Italy

RECRUITING

Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica

Ancona, 60100, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

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

Milan, 20162, Italy

RECRUITING

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

Naples, 80131, Italy

RECRUITING

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

Padova, 35128, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

Pisa, 56126, Italy

RECRUITING

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

Reggio Emilia, Italy

RECRUITING

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

Roma, Italy

RECRUITING

National Cancer Center Hospital

Chūōku, Japan

RECRUITING

Nara Medical University Hospital - Dept of Oncology

Kashihara-shi, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Kōtoku, Japan

RECRUITING

Saiseikai Kumamoto Hospital - 300175708

Kumamoto, Japan

RECRUITING

Kurume University Hospital

Kurume-shi, Japan

RECRUITING

Niigata Cancer Center Hospital - 300176282

Niigata, Japan

RECRUITING

Kindai University Hospital

Osakasayama-shi, Japan

RECRUITING

NHO Hokkaido Cancer Center - 300175802

Sapporo, Japan

RECRUITING

Chonnam National University Hwasun Hospital

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

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

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

Seoul, South Korea

RECRUITING

Hospital Universitario Reina Sofia - Dept of Oncology

Córdoba, Córdoba, 14004, Spain

RECRUITING

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

Badalona, Spain

RECRUITING

Hospital Universitari Vall d'Hebron - Oncology Dept.

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona - Servicio de Oncologia

Barcelona, 08036, Spain

RECRUITING

Hospital HM Nou Delfos - START Barcelona

Barcelona, Spain

RECRUITING

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

L'Hospitalet de Llobregat, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

Madrid, 28007, Spain

RECRUITING

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

Madrid, Spain

RECRUITING

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

Madrid, Spain

RECRUITING

Hospital Universitario Ramon y Cajal - Servicio de Oncologia

Madrid, Spain

RECRUITING

NEXT Madrid - Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Spain

RECRUITING

Hospital Universitario Virgen Macarena - Oncology Service

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe - Oncology Department

Valencia, 46026, Spain

RECRUITING

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Central Study Contacts

Communication Center

CONTACT

+496151725200; service@emdgroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 29, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): December 23, 2027
• Study Completion (Estimated): December 23, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

KR (9); FR (10); US (8); JP (8); ES (14); IT (9); AU (3); DE (6); CN (10)