Phase
Condition
Stomach Cancer
Pancreatitis
Solid Tumors
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
Mater Misericordiae Ltd - PARENT
South Brisbane,
AustraliaActive - Recruiting
Macquarie University Hospital - PARENT
Sydney,
AustraliaActive - Recruiting
Centre Georges François Leclerc - Unité de Phase I
Dijon cedex,
FranceActive - Recruiting
Centre Oscar Lambret - cancerologie generale
Lille Cedex,
FranceActive - Recruiting
Hôpital Européen Georges Pompidou - Hématologie Oncologie
Paris Cedex 15,
FranceActive - Recruiting
Hôpital Saint-Antoine - Oncologie Médicale
Paris cedex 12,
FranceActive - Recruiting
ICO - Site René Gauducheau - Service d'Oncologie medicale
Saint Herblain,
FranceActive - Recruiting
Hôpital Foch - Service d'Oncologie Médicale
Suresnes Cedex,
FranceActive - Recruiting
Hopital Rangueil - Service d'Oncologie médicale
Toulouse,
FranceActive - Recruiting
Research Site
Darmstadt,
GermanySite Not Available
National Cancer Center Hospital
Chuo-ku,
JapanActive - Recruiting
Nara Medical University Hospital - Dept of Oncology
Kashihara-shi,
JapanActive - Recruiting
Cancer Institute Hospital of JFCR
Koto-ku,
JapanActive - Recruiting
Saiseikai Kumamoto Hospital - 300175708
Kumamoto-shi,
JapanActive - Recruiting
Kurume University Hospital
Kurume-shi,
JapanActive - Recruiting
Niigata Cancer Center Hospital - 300176282
Niigata-shi,
JapanActive - Recruiting
NHO Hokkaido Cancer Center - 300175802
Sapporo-shi,
JapanActive - Recruiting
Pusan National University Hospital
Busan,
Korea, Republic ofActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu,
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun,
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital
Seongnam,
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul,
Korea, Republic ofActive - Recruiting
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
University of California - Los Angeles - 300208353
Santa Monica, California 90404
United StatesActive - Recruiting
Providence Medical Foundation
Santa Rosa, California 95403
United StatesActive - Recruiting
Research Site
Billerica, Massachusetts 01821
United StatesSite Not Available
Prisma Health Cancer Institute, ITOR, CRU
Greenville, South Carolina 29605
United StatesActive - Recruiting
Baptist Memorial Health Care -Memphis
Memphis, Tennessee 38120
United StatesActive - Recruiting
University of Texas M. D. Anderson Cancer Center - Partner
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
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