Solid TumorsPhase 1/2NCT06710132
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
A Phase 1/2 study testing M9140 in people with Solid Tumors and Gastric Cancer, run by EMD Serono Research & Development Institute, Inc. at 81 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- M9140
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 81 sitesin 10 countries
- Study dates
- 29 Jan 2025to 23 Dec 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 24Show fewer
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
81 sites in 10 countries.
81 sites in 10 countries
Spain14 sites
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, 08035
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona, 08036
Hospital HM Nou Delfos - START Barcelona
Barcelona
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba, Córdoba, 14004
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid, 28007
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, 41009
Hospital Universitario Virgen de Valme
Seville, 41014
Hospital Universitari i Politecnic La Fe - Oncology Department
Valencia, 46026
China10 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Xiangya Hospital, Central South University
Changsha, Hu'nan, 410000
Sichuan Cancer Hospital
Chengdu, Sichuan, 610176
West China Hospital, Sichuan University
Chengdu, Sichuan, 611100
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou, 510060
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery
Hangzhou, Zhejiang, 156022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230088
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hebei, 430021
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
France10 sites
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
Institut Claudius Regaud - Service d'oncologie médicale
Toulouse
Institut Gustave Roussy - Pathologie Thoracique
Villejuif
Italy9 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica
Ancona, 60100
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck
Milan, 20162
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia
Naples, 80131
IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi
Padova, 35128
Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II
Pisa, 56126
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, 00144
South Korea9 sites
Pusan National University Hospital
Busan
Kyungpook National University Chilgok Hospital
Daegu
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128
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
United States8 sites
NEXT Virginia
Fairfax, Virginia, 22031
Prisma Health Cancer Institute, ITOR, CRU
Greenville, South Carolina, 29605
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
D&H Cancer Research Center
Margate, Florida, 33063
Baptist Cancer Center
Memphis, Tennessee, 38120
University of California - Los Angeles - 300208353
Santa Monica, California, 90404
Providence Medical Foundation
Santa Rosa, California, 95403
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
Washington D.C., District of Columbia, 20007
Japan8 sites
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
Germany6 sites
Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center
Berlin, 10117
St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und Palliativmedizin
Bochum, North Rhine-Westphalia, 44791
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden, Saxony, 01307
Krankenhaus Nordwest GmbH - Neurologische Klinik
Frankfurt am Main, Hesse, 60488
Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)
Leipzig, Saxony, 04103
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.
Mainz, Rhineland-Palatinate, 55131
Australia4 sites
Flinders Medical Centre
Bedford Park
Nepean Cancer Care Centre
Kingswood
Mater Misericordiae Ltd - PARENT
South Brisbane
Macquarie University Hospital - PARENT
Sydney
Austria3 sites
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, 1090
About this study
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)
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).
Read the detailed description
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.
- Conditions
- Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- M9140
- Keywords
- ADC, TOP1 inhibitor, Gastric Cancer, Gastroesophageal junction cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer, Solid Tumors
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M9140Drug
Also called Precemtabart tocentecan
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.
| Study group | Role | What they receive |
|---|---|---|
| Substudy GC: M9140 Monotherapy - Part A CEACAM5 High | Experimental | Not described Receives: Drug: M9140 |
| Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low | Experimental | Not described Receives: Drug: M9140 |
| Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt | Experimental | Not described Receives: Drug: M9140 |
| Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut | Experimental | Not described Receives: Drug: M9140 |
| Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High | Experimental | Not described Receives: Drug: M9140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Time from first study treatment to (planned) final assessment at approximately 48 months
Substudies GC/NSCLC/PDAC: Number of Participants with Disease Control
Measured: At Week 12
Substudies GC/NSCLC/PDAC: Time to Response according to RECIST v1.1 as Assessed by Investigators
Measured: 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
Measured: Time from first study treatment throughout the study duration until progressive disease or death due to any cause, whichever occur first, approximately 48 months
Substudies GC/ NSCLC/ PDAC: Pharmacokinetic (PK) Plasma Concentrations of M9140
Measured: Cycle (C) 1 Day (D) 1 to C3D15, C4D1 and from C8D1 every 4 cycles on D1 until treatment discontinuation (each cycle is of 21 days), assessed up to approximately 12 months
Substudies GC/NSCLC/PDAC: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140
Measured: Predose (C1D1, C3D1, C8D1) and end of study intervention, assessed up to approximately 12 months
Substudy GC: CEACAM5 expression in tumor
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start29 Jan 2025
- Primary completion23 Dec 2027 (estimated)
- Study completion23 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710132
- Sponsor's protocol ID
- MS202329_0010
- Other IDs
- 2024-517817-34-00, 2024-517818-15-00, 2024-517819-74-00, CTR20250902, jRCT2071240131
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD supporting publicly available results will be evaluated for sharing.