Actively Recruiting
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-04-29
250
Participants Needed
81
Research Sites
151 weeks
Total Duration
On this page
Sponsors
E
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
M
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants able to sign informed consent
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Adequate blood, liver, and kidney function as defined in the protocol
- At least one measurable tumor lesion by RECIST v1.1
- Other protocol-specific inclusion criteria
- Substudy GC: Histologically confirmed advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma; must have progressed after 1 to 2 prior systemic therapies including fluoropyrimidine, platinum, and immune checkpoint inhibitors if applicable
- Substudy GC Part A: CEACAM5 high expression (IHC ≥ 2+ in ≥ 50% tumor cells)
- Substudy GC Part B: CEACAM5 low expression (IHC ≥ 2+ in < 50% tumor cells)
- Substudy NSCLC: Histologically or cytologically confirmed advanced/metastatic NSCLC; progressed after 1 to 3 prior systemic therapies; must have received platinum-containing or targeted therapy if given as neoadjuvant/adjuvant with relapse within 3 months
- Substudy NSCLC Part A: CEACAM5 high-expressing EGFR tumors without EGFR mutations
- Substudy NSCLC Part B: CEACAM5 high-expressing EGFR mutated tumors
- Substudy PDAC: Histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma; progressed after 1 to 2 prior systemic therapies including FOLFIRINOX, NALIRIFNOX, or nab-paclitaxel/gemcitabine
- Substudy PDAC: CEACAM5 high expression confirmed by IHC
- Other protocol-specific inclusion criteria
You will not qualify if you...
- History of malignancy within 3 years except treated skin cancers, cervical carcinoma in situ, benign prostate conditions, or cancers considered cured with minimal recurrence risk
- Known brain metastases unless treated and stable for at least 4 weeks with no ongoing neurologic symptoms
- Diarrhea (liquid stool) or ileus greater than grade 1
- Active chronic inflammatory bowel disease or bowel obstruction
- Cardiac issues including arrhythmia, unstable angina, recent myocardial infarction, congestive heart failure NYHA class II or higher, or coronary revascularization within 180 days
- QTc interval greater than 470 ms
- Stroke within 6 months prior to enrollment
- Substudy GC and NSCLC: prior therapy with irinotecan
- Other protocol-specific exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 81 locations
1
University of California - Los Angeles - 300208353
Santa Monica, California, United States, 90404
Actively Recruiting
2
Providence Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
3
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
Washington D.C., District of Columbia, United States, 20007
Active, Not Recruiting
4
D&H Cancer Research Center
Margate, Florida, United States, 33063
Actively Recruiting
5
Prisma Health Cancer Institute, ITOR, CRU
Greenville, South Carolina, United States, 29605
Actively Recruiting
6
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
9
Flinders Medical Centre
Bedford Park, Australia
Actively Recruiting
10
Nepean Cancer Care Centre
Kingswood, Australia
Actively Recruiting
11
Mater Misericordiae Ltd - PARENT
South Brisbane, Australia
Actively Recruiting
12
Macquarie University Hospital - PARENT
Sydney, Australia
Actively Recruiting
13
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology
Linz, Austria
Actively Recruiting
14
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg, Austria
Actively Recruiting
15
Medical University of Vienna - Department of Internal Medicine
Vienna, Austria, 1090
Actively Recruiting
16
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230088
Actively Recruiting
17
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
18
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, China, 510060
Actively Recruiting
19
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hebei, China, 430021
Actively Recruiting
20
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
21
Xiangya Hospital, Central South University
Changsha, Hu'nan, China, 410000
Actively Recruiting
22
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
23
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610176
Actively Recruiting
24
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 611100
Actively Recruiting
25
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery
Hangzhou, Zhejiang, China, 156022
Actively Recruiting
26
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux, France
Actively Recruiting
27
Centre Georges François Leclerc - Unité de Phase I
Dijon, France
Actively Recruiting
28
Centre Oscar Lambret - cancerologie generale
Lille, France
Actively Recruiting
29
Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon
Lille, France
Actively Recruiting
30
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris, France
Actively Recruiting
31
Hôpital Saint-Antoine - Oncologie Médicale
Paris, France
Actively Recruiting
32
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain, France
Actively Recruiting
33
Hôpital Foch - Service d'Oncologie Médicale
Suresnes, France
Actively Recruiting
34
Institut Claudius Regaud - Service d'oncologie médicale
Toulouse, France
Actively Recruiting
35
Institut Gustave Roussy - Pathologie Thoracique
Villejuif, France
Actively Recruiting
36
Krankenhaus Nordwest GmbH - Neurologische Klinik
Frankfurt am Main, Hesse, Germany, 60488
Actively Recruiting
37
St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und Palliativmedizin
Bochum, North Rhine-Westphalia, Germany, 44791
Actively Recruiting
38
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
39
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden, Saxony, Germany, 01307
Actively Recruiting
40
Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)
Leipzig, Saxony, Germany, 04103
Actively Recruiting
41
Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center
Berlin, Germany, 10117
Actively Recruiting
42
Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B
Rome, Roma, Italy, 00144
Actively Recruiting
43
Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica
Ancona, Italy, 60100
Actively Recruiting
44
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
45
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck
Milan, Italy, 20162
Actively Recruiting
46
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia
Naples, Italy, 80131
Actively Recruiting
47
IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi
Padova, Italy, 35128
Actively Recruiting
48
Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II
Pisa, Italy, 56126
Actively Recruiting
49
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di Oncologia
Reggio Emilia, Italy
Actively Recruiting
50
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
Roma, Italy
Actively Recruiting
51
National Cancer Center Hospital
Chūōku, Japan
Actively Recruiting
52
Nara Medical University Hospital - Dept of Oncology
Kashihara-shi, Japan
Actively Recruiting
53
Cancer Institute Hospital of JFCR
Kōtoku, Japan
Actively Recruiting
54
Saiseikai Kumamoto Hospital - 300175708
Kumamoto, Japan
Actively Recruiting
55
Kurume University Hospital
Kurume-shi, Japan
Actively Recruiting
56
Niigata Cancer Center Hospital - 300176282
Niigata, Japan
Actively Recruiting
57
Kindai University Hospital
Osakasayama-shi, Japan
Actively Recruiting
58
NHO Hokkaido Cancer Center - 300175802
Sapporo, Japan
Actively Recruiting
59
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea, 58128
Actively Recruiting
60
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
61
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Actively Recruiting
62
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
63
Asan Medical Center
Seoul, South Korea
Actively Recruiting
64
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
65
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
66
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
67
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul, South Korea
Actively Recruiting
68
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba, Córdoba, Spain, 14004
Actively Recruiting
69
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona, Spain
Actively Recruiting
70
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, Spain, 08035
Actively Recruiting
71
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona, Spain, 08036
Actively Recruiting
72
Hospital HM Nou Delfos - START Barcelona
Barcelona, Spain
Actively Recruiting
73
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat, Spain
Actively Recruiting
74
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid, Spain, 28007
Actively Recruiting
75
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid, Spain
Actively Recruiting
76
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid, Spain
Actively Recruiting
77
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid, Spain
Actively Recruiting
78
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain
Actively Recruiting
79
Hospital Universitario Virgen Macarena - Oncology Service
Seville, Spain, 41009
Actively Recruiting
80
Hospital Universitario Virgen de Valme
Seville, Spain, 41014
Actively Recruiting
81
Hospital Universitari i Politecnic La Fe - Oncology Department
Valencia, Spain, 46026
Actively Recruiting
Research Team
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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