Phase
Condition
Pancreatic Cancer
Digestive System Neoplasms
Esophageal Cancer
Treatment
AZD5863
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Age ≥ 18 at the time of signing the informed consent
Histologically confirmed diagnosis of adenocarcinoma of the stomach,gastro-esophageal junction, esophagus, or pancreas
Must have at least one measurable lesion according to Response Evaluation Criteriain Solid Tumors (RECIST) v1.1
Must show positive CLDN18.2 expression in tumor cells as determined by centralimmunohistochemistry (IHC)
Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
Predicted life expectancy of ≥ 12 weeks
Adequate organ and bone marrow function measured within 28 days prior to first doseas defined by the protocol
Contraceptive use by men or women should be consistent with local regulations, asdefined by the protocol
Must have received at least one prior line of systemic therapy in theadvanced/metastatic setting
Exclusion
Key Exclusion Criteria:
Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria forAdverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
Participant experienced unacceptable cytokine release syndrome (CRS) or ImmuneEffector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE)or chimeric antigen receptor T (CAR-T) cell therapy
Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activationsyndrome (MAS)
Active or prior documented autoimmune or inflammatory disorders within 3 years ofstart of treatment
central nervous system (CNS) metastases or CNS pathology, as defined by theprotocol, within 3 months prior to consent
Infectious disease including active human immunodeficiency virus (HIV), activehepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal,bacterial or other infection
Cardiac conditions as defined by the protocol
History of thromboembolic event within the past 3 months prior to the scheduledfirst dose of study intervention
Participant requires chronic immunosuppressive therapy
Participants on anticoagulation therapy
Study Design
Study Description
Connect with a study center
Research Site
Beijing, 101199
ChinaActive - Recruiting
Research Site
Shandong,
ChinaActive - Recruiting
Research Site
Toulouse, 31059
FranceActive - Recruiting
Research Site
Toulouse Cedex 09, 31059
FranceSite Not Available
Research Site
Villejuif Cedex, 94805
FranceActive - Recruiting
Research Site
Chuo-ku, 104-0045
JapanActive - Recruiting
Research Site
Kashiwa, 227-8577
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Seodaemun-gu, 03722
Korea, Republic ofSite Not Available
Research Site
Seoul, 03722
Korea, Republic ofActive - Recruiting
Research Site
Amsterdam, 1081 HV
NetherlandsActive - Recruiting
Research Site
Groningen, 9713 GZ
NetherlandsActive - Recruiting
Research Site
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Research Site
Kaohsiung, 80756
TaiwanActive - Recruiting
Research Site
Tainan, 704
TaiwanSite Not Available
Research Site
Tainan City, 70403
TaiwanActive - Recruiting
Research Site
Taoyuan, 00333
TaiwanActive - Recruiting
Research Site
Dundee, DD1 9SY
United KingdomActive - Recruiting
Research Site
London, E1 1BB
United KingdomActive - Recruiting
Research Site
Oxford, OX3 7LE
United KingdomActive - Recruiting
Research Site
Wirral, CH63 4JY
United KingdomActive - Recruiting
Research Site
Jacksonville, Florida 32224
United StatesActive - Recruiting
Research Site
Rochester, Minnesota 55905
United StatesActive - Recruiting
Research Site
New York, New York 10065
United StatesSite Not Available
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