Phase
Condition
Esophageal Cancer
Gastric Cancer
Pancreatic 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 with long-acting anticoagulants or otherclass of anticoagulants at therapeutic doses
Study Design
Study Description
Connect with a study center
Research Site
Beijing, 101199
ChinaSite Not Available
Research Site
Beijing 1816670, 101199
ChinaActive - Recruiting
Research Site
Shandong,
ChinaSite Not Available
Research Site
Shandong 9617160,
ChinaActive - Recruiting
Research Site
Toulouse, 31059
FranceSite Not Available
Research Site
Toulouse 2972315, 31059
FranceActive - Recruiting
Research Site
Toulouse Cedex 09, 31059
FranceSite Not Available
Research Site
Villejuif 2968705, 94805
FranceActive - Recruiting
Research Site
Villejuif Cedex, 94805
FranceSite Not Available
Research Site
Chuo-ku, 104-0045
JapanSite Not Available
Research Site
Chūōku 10262791, 104-0045
JapanActive - Recruiting
Research Site
Kashiwa, 227-8577
JapanSite Not Available
Research Site
Kashiwa 1859924, 227-8577
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanSite Not Available
Research Site
Kōtoku 2128852, 135-8550
JapanActive - Recruiting
Research Site
Seodaemun-gu, 03722
Korea, Republic ofSite Not Available
Research Site
Seoul, 03722
Korea, Republic ofSite Not Available
Research Site
Amsterdam, 1081 HV
NetherlandsSite Not Available
Research Site
Amsterdam 2759794, 1081 HV
NetherlandsActive - Recruiting
Research Site
Groningen, 9713 GZ
NetherlandsSite Not Available
Research Site
Groningen 2755251, 9713 GZ
NetherlandsActive - Recruiting
Research Site
Rotterdam, 3015 GD
NetherlandsSite Not Available
Research Site
Rotterdam 2747891, 3015 GD
NetherlandsActive - Recruiting
Research Site
Seoul 1835848, 03722
South KoreaActive - Recruiting
Research Site
Kaohsiung, 80756
TaiwanSite Not Available
Research Site
Kaohsiung City 1673820, 80756
TaiwanActive - Recruiting
Research Site
Tainan, 704
TaiwanSite Not Available
Research Site
Tainan 1668355, 70403
TaiwanActive - Recruiting
Research Site
Tainan City, 70403
TaiwanSite Not Available
Research Site
Tainan City 1668355, 70403
TaiwanSite Not Available
Research Site
Taoyuan, 00333
TaiwanSite Not Available
Research Site
Taoyuan District 1667905, 00333
TaiwanActive - Recruiting
Research Site
Dundee, DD1 9SY
United KingdomSite Not Available
Research Site
Dundee 2650752, DD1 9SY
United KingdomActive - Recruiting
Research Site
London, E1 1BB
United KingdomSite Not Available
Research Site
London 2643743, E1 1BB
United KingdomActive - Recruiting
Research Site
Metropolitan Borough of Wirral 7733088, CH63 4JY
United KingdomActive - Recruiting
Research Site
Oxford, OX3 7LE
United KingdomSite Not Available
Research Site
Oxford 2640729, OX3 7LE
United KingdomActive - Recruiting
Research Site
Wirral, CH63 4JY
United KingdomSite Not Available
Research Site
Jacksonville, Florida 32224
United StatesSite Not Available
Research Site
Jacksonville 4160021, Florida 4155751 32224
United StatesActive - Recruiting
Research Site
Rochester, Minnesota 55905
United StatesSite Not Available
Research Site
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Research Site
New York, New York 10065
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10065
United StatesSite Not Available

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