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NCT06710132Active, not recruitingPhase 1/2

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

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)

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
184 (actual)
First submitted
22 Nov 2024
Start date
29 Jan 2025
Primary completion date
23 Dec 2027
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT06710132
EU CT number
2024-517817-34-00
EudraCT number
2024-517818-15

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 184
  • From 29 Jan 2025 to the primary completion date, 23 Dec 2027
  • 74 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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

Other illness

  • 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 active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction

Lab values

  • 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)

Other

  • Participants with diarrhea (liquid stool) or ileus Grade \> 1

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (74)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SCRI CCCIT Ges.m.b.H.
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SalzburgAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Nepean Cancer Care Centre
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KingswoodAustraliaUnknown status
Mater Misericordiae Ltd - PARENT
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South BrisbaneAustraliaUnknown status
Macquarie University Hospital - PARENT
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SydneyAustraliaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Anhui Provincial Cancer Hospital
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HefeiChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
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WuhanChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Katholisches Klinikum Bochum gGmbH
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BochumGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyActive, not recruiting
Universitaet Leipzig
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LeipzigGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital HM Nou Delfos
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
Institut Bergonie
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BordeauxFranceActive, not recruiting
Centr Georges Francois Leclerc
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DijonFranceActive, not recruiting
Centre Oscar Lambret
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LilleFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hopital Saint Antoine
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Paris Cedex 12FranceActive, not recruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceActive, not recruiting
Hospital Foch
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SuresnesFranceActive, not recruiting
Oncopole Claudius Regaud
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Toulouse Cedex 9FranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
National Cancer Center Hospital
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ChūōkuJapanUnknown status
Nara Medical University Hospital - Dept of Oncology
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Kashihara-shiJapanUnknown status
Cancer Institute Hospital of JFCR
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KōtokuJapanUnknown status
Saiseikai Kumamoto Hospital - 300175708
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KumamotoJapanUnknown status
Kurume University Hospital
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Kurume-shiJapanUnknown status
Niigata Cancer Center Hospital - 300176282
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NiigataJapanUnknown status
Kindai University Hospital
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Osakasayama-ShiJapanUnknown status
NHO Hokkaido Cancer Center - 300175802
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SapporoJapanUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Hwasun-gunSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
NEXT Virginia
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FairfaxUnited StatesUnknown status
Prisma Health Cancer Institute, ITOR, CRU
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GreenvilleUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
D & H Cancer Research Center
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MargateUnited StatesUnknown status
Baptist Cancer Center
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MemphisUnited StatesUnknown status
University of California - Los Angeles - 300208353
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Santa MonicaUnited StatesUnknown status
Providence Medical Foundation
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Santa RosaUnited StatesUnknown status
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.