Phase
Condition
Pancreatitis
Solid Tumors
Digestive System Neoplasms
Treatment
M9140
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 inprotocol
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 ofadvanced or metastatic, HER2 negative, gastric or GEJ (with an epicenter 2centimeter (cm) proximal or distal to the GEJ) adenocarcinoma, who wereintolerant/refractory to or progressed after systemic therapies for theadvanced/metastatic stage that must have included (provided there is no medicalcontraindication and these agents are locally approved and available) afluoropyrimidine and a platinum agent and an Immune checkpoint inhibitors (ICI) forparticipants with a known microsatellite instability-high (MSI-H) status orparticipants 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 inless 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 documentedadvanced (Stage III not eligible for resection or curative radiation) or metastaticNSCLC with or without driver genomic alterations
Participants must have been intolerant/refractory to or progressed after systemictherapies 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 occurredduring or within 3 months after regimen completion, are considered to have receiveda line of treatment in the advanced setting
Participants in Part A with CEACAM5 high-expressing EGFR tumors (includingparticipants with any driver genomic alterations other than EGFR mutations
Participants in Part B with CEACAM5 high known EGFR mutated tumors as assessedaccording to local clinical practice
Other protocol defined inclusion criteria could apply
Substudy PDAC:
Participants with histologically or cytologically confirmed advanced or metastaticPDAC, who were intolerant/refractory to or progressed after systemic therapies forthe advanced metastatic stage that must have included (provided there is no medicalcontraindications, and these agents are locally approved and available; FOLFIRINOXregimen or NALIRIFNOX regimen or Nab-paclitaxel/gemcitabine regimen
Participants must have received and progressed (according to RECIST 1.1) on at leastone 1 line of therapy for the treatment of advanced/metastatic disease but no morethan 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
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 situof the cervix, benign prostate neoplasm/hypertropia, or malignancy that in theopinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, isconsidered cured with minimal risk of recurrence within 3 years)
Participants with known brain metastases, except those meeting the followingcriteria: Brain metastases that have been treated locally and are clinically stablefor at least 4 weeks prior to the start of treatment; No ongoing neurologicalsymptoms that are related to the brain localization of the disease (sequelae thatare 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., ulcerativecolitis, 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 procedurewithin 180 days of study entry. Calculated QTc average (using the Fridericiacorrection 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
Study Design
Study Description
Connect with a study center
Flinders Medical Centre
Bedford Park,
AustraliaActive - Recruiting
Flinders Medical Centre
Bedford Park 2076918,
AustraliaSite Not Available
Nepean Cancer Care Centre
Kingswood,
AustraliaActive - Recruiting
Nepean Cancer Care Centre
Kingswood 2161303,
AustraliaSite Not Available
Mater Misericordiae Ltd - PARENT
South Brisbane,
AustraliaActive - Recruiting
Mater Misericordiae Ltd - PARENT
South Brisbane 2207259,
AustraliaSite Not Available
Macquarie University Hospital - PARENT
Sydney,
AustraliaActive - Recruiting
Macquarie University Hospital - PARENT
Sydney 2147714,
AustraliaSite Not Available
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology
Linz,
AustriaActive - Recruiting
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology
Linz 2772400,
AustriaSite Not Available
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg,
AustriaActive - Recruiting
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
Salzburg 2766824,
AustriaSite Not Available
Medical University of Vienna - Department of Internal Medicine
Vienna, 1090
AustriaActive - Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui 230088
ChinaActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality 100142
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangzhou 510060
ChinaActive - Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hebei 430021
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150081
ChinaActive - Recruiting
Xiangya Hospital, Central South University
Changsha, Hu'nan 410000
ChinaActive - Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei 430030
ChinaActive - Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan 610176
ChinaActive - Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan 611100
ChinaActive - Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery
Hangzhou, Zhejiang 156022
ChinaActive - Recruiting
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux,
FranceActive - Recruiting
Institut Bergonié - Service d'Oncologie Médicale
Bordeaux 3031582,
FranceSite Not Available
Centre Georges François Leclerc - Unité de Phase I
Dijon,
FranceActive - Recruiting
Centre Georges François Leclerc - Unité de Phase I
Dijon 3021372,
FranceSite Not Available
Centre Georges François Leclerc - Unité de Phase I
Dijon cedex,
FranceSite Not Available
Centre Oscar Lambret - cancerologie generale
Lille,
FranceActive - Recruiting
Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon
Lille,
FranceActive - Recruiting
Centre Oscar Lambret - cancerologie generale
Lille 2998324,
FranceSite Not Available
Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon
Lille 2998324,
FranceActive - Recruiting
Centre Oscar Lambret - cancerologie generale
Lille Cedex,
FranceSite Not Available
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris,
FranceActive - Recruiting
Hôpital Saint-Antoine - Oncologie Médicale
Paris,
FranceActive - Recruiting
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris 2988507,
FranceSite Not Available
Hôpital Saint-Antoine - Oncologie Médicale
Paris 2988507,
FranceActive - Recruiting
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris Cedex 15,
FranceSite Not Available
Hôpital Saint-Antoine - Oncologie Médicale
Paris cedex 12,
FranceSite Not Available
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint Herblain,
FranceSite Not Available
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain,
FranceActive - Recruiting
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint-Herblain 2979590,
FranceSite Not Available
Hôpital Foch - Service d'Oncologie Médicale
Suresnes,
FranceActive - Recruiting
Hôpital Foch - Service d'Oncologie Médicale
Suresnes 2973675,
FranceSite Not Available
Hôpital Foch - Service d'Oncologie Médicale
Suresnes Cedex,
FranceSite Not Available
Hopital Rangueil - Service d'Oncologie médicale
Toulouse,
FranceActive - Recruiting
Institut Claudius Regaud - Service d'oncologie médicale
Toulouse,
FranceActive - Recruiting
Hopital Rangueil - Service d'Oncologie médicale
Toulouse 2972315,
FranceSite Not Available
Institut Gustave Roussy - Pathologie Thoracique
Villejuif,
FranceActive - Recruiting
Institut Gustave Roussy - Pathologie Thoracique
Villejuif 2968705,
FranceSite Not Available
Krankenhaus Nordwest GmbH - Neurologische Klinik
Frankfurt am Main, Hesse 60488
GermanyActive - Recruiting
St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und Palliativmedizin
Bochum, North Rhine-Westphalia 44791
GermanyActive - Recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.
Mainz, Rhineland-Palatinate 55131
GermanyActive - Recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I
Dresden, Saxony 01307
GermanyActive - Recruiting
Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)
Leipzig, Saxony 04103
GermanyActive - Recruiting
Charité - Campus Charité Mitte - Charité Comprehensive Cancer Center
Berlin, 10117
GermanyActive - Recruiting
Research Site
Darmstadt,
GermanySite Not Available
Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B
Rome, Roma 00144
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica
Ancona, 60100
ItalyActive - Recruiting
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck
Milan, 20162
ItalyActive - Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
ItalyActive - Recruiting
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di Oncologia
Reggio Emilia,
ItalyActive - Recruiting
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di Oncologia
Reggio Emilia 3169522,
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
Roma,
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche
Roma 8957247,
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica
Torrette Di Ancona,
ItalySite Not Available
National Cancer Center Hospital
Chuo-ku,
JapanSite Not Available
National Cancer Center Hospital
Chūōku,
JapanActive - Recruiting
National Cancer Center Hospital
Chūōku 10262791,
JapanSite Not Available
Nara Medical University Hospital - Dept of Oncology
Kashihara-shi,
JapanActive - Recruiting
Nara Medical University Hospital - Dept of Oncology
Kashihara-shi 1859951,
JapanSite Not Available
Cancer Institute Hospital of JFCR
Koto-ku,
JapanSite Not Available
Saiseikai Kumamoto Hospital - 300175708
Kumamoto,
JapanActive - Recruiting
Saiseikai Kumamoto Hospital - 300175708
Kumamoto 1858421,
JapanSite Not Available
Saiseikai Kumamoto Hospital - 300175708
Kumamoto-shi,
JapanSite Not Available
Kurume University Hospital
Kurume-shi,
JapanActive - Recruiting
Cancer Institute Hospital of JFCR
Kōtoku,
JapanActive - Recruiting
Cancer Institute Hospital of JFCR
Kōtoku 2128852,
JapanSite Not Available
Niigata Cancer Center Hospital - 300176282
Niigata,
JapanActive - Recruiting
Niigata Cancer Center Hospital - 300176282
Niigata 1855431,
JapanSite Not Available
Niigata Cancer Center Hospital - 300176282
Niigata-shi,
JapanSite Not Available
Kindai University Hospital
Osakasayama-shi,
JapanActive - Recruiting
NHO Hokkaido Cancer Center - 300175802
Sapporo,
JapanActive - Recruiting
NHO Hokkaido Cancer Center - 300175802
Sapporo 2128295,
JapanSite Not Available
NHO Hokkaido Cancer Center - 300175802
Sapporo-shi,
JapanSite Not Available
Pusan National University Hospital
Busan,
Korea, Republic ofSite Not Available
Kyungpook National University Chilgok Hospital
Daegu,
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Hwasun-gun,
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam,
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul,
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul,
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do 58128
South KoreaActive - Recruiting
Pusan National University Hospital
Busan,
South KoreaActive - Recruiting
Pusan National University Hospital
Busan 1838524,
South KoreaSite Not Available
Kyungpook National University Chilgok Hospital
Daegu,
South KoreaActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu 1835329,
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seongnam,
South KoreaActive - Recruiting
Seoul National University Bundang Hospital
Seongnam 6876792,
South KoreaSite Not Available
Asan Medical Center
Seoul,
South KoreaActive - Recruiting
Korea University Guro Hospital
Seoul,
South KoreaActive - Recruiting
Samsung Medical Center
Seoul,
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul,
South KoreaActive - Recruiting
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul,
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848,
South KoreaActive - Recruiting
Korea University Guro Hospital
Seoul 1835848,
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848,
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848,
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
Seoul 1835848,
South KoreaActive - Recruiting
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba, Córdoba 14004
SpainActive - Recruiting
Hospital Universitario Reina Sofia - Dept of Oncology
Córdoba 2519240, Córdoba 14004
SpainSite Not Available
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona,
SpainActive - Recruiting
ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona 3129028,
SpainSite Not Available
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona, 08036
SpainActive - Recruiting
Hospital HM Nou Delfos - START Barcelona
Barcelona,
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona, 08035
SpainActive - Recruiting
Hospital Clinic de Barcelona - Servicio de Oncologia
Barcelona 3128760, 08036
SpainActive - Recruiting
Hospital HM Nou Delfos - START Barcelona
Barcelona 3128760,
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron - Oncology Dept.
Barcelona 3128760, 08035
SpainSite Not Available
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat,
SpainActive - Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat 3120619,
SpainSite Not Available
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid,
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid,
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid,
SpainActive - Recruiting
Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica
Madrid 3117735,
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica
Madrid 3117735, 28007
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I
Madrid 3117735,
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal - Servicio de Oncologia
Madrid 3117735,
SpainActive - Recruiting
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón,
SpainActive - Recruiting
NEXT Madrid - Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón 3112989,
SpainSite Not Available
Hospital Universitario Virgen Macarena - Oncology Service
Seville, 41009
SpainActive - Recruiting
Hospital Universitario Virgen de Valme
Seville, 41014
SpainActive - Recruiting
Hospital Universitario Virgen Macarena - Oncology Service
Seville 2510911, 41009
SpainActive - Recruiting
Hospital Universitario Virgen de Valme
Seville 2510911, 41014
SpainSite Not Available
Hospital Universitari i Politecnic La Fe - Oncology Department
Valencia, 46026
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe - Oncology Department
Valencia 2509954, 46026
SpainSite Not Available
University of California - Los Angeles - 300208353
Santa Monica, California 90404
United StatesActive - Recruiting
Providence Medical Foundation
Santa Rosa, California 95403
United StatesActive - Recruiting
University of California - Los Angeles - 300208353
Santa Monica 5393212, California 5332921 90404
United StatesSite Not Available
Providence Medical Foundation
Santa Rosa 5393287, California 5332921 95403
United StatesSite Not Available
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
Washington D.C., District of Columbia 20007
United StatesSite Not Available
Georgetown University - Lombardi Comprehensive Cancer Center - 1134847
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesSite Not Available
D&H Cancer Research Center
Margate, Florida 33063
United StatesActive - Recruiting
Memorial Cancer Institute at Memorial Healthcare System
Pembroke Pines, Florida 33026
United StatesActive - Recruiting
D&H Cancer Research Center
Margate 4163407, Florida 4155751 33063
United StatesSite Not Available
Memorial Cancer Institute at Memorial Healthcare System
Pembroke Pines 4168139, Florida 4155751 33026
United StatesSite Not Available
Research Site
Billerica, Massachusetts 01821
United StatesSite Not Available
Prisma Health Cancer Institute, ITOR, CRU
Greenville, South Carolina 29605
United StatesActive - Recruiting
Prisma Health Cancer Institute, ITOR, CRU
Greenville 4580543, South Carolina 4597040 29605
United StatesSite Not Available
Baptist Cancer Center
Memphis, Tennessee 38120
United StatesActive - Recruiting
Baptist Memorial Health Care -Memphis
Memphis, Tennessee 38120
United StatesActive - Recruiting
Baptist Cancer Center
Memphis 4641239, Tennessee 4662168 38120
United StatesSite Not Available
Baptist Memorial Health Care -Memphis
Memphis 4641239, Tennessee 4662168 38120
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
University of Texas M. D. Anderson Cancer Center - Partner
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
University of Texas M. D. Anderson Cancer Center - Partner
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
NEXT Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
NEXT Virginia
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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