Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring CLDN18.2 / Claudin 18.2, CD3, T cell-engaging bi-specific antibody, Gastric cancer, Gastro-esophageal junction cancer, Pancreatic ductal adenocarcinoma, Solid tumors, AZD5863
Eligibility Criteria
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 Criteria in Solid Tumors (RECIST) v1.1 Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (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 dose as defined by the protocol Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol Must have received at least one prior line of systemic therapy in the advanced/metastatic setting Key Exclusion Criteria: Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B/C, 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 scheduled first dose of study intervention Participant requires chronic immunosuppressive therapy Participants on anticoagulation therapy
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research SiteRecruiting
- Research SiteRecruiting
- Research SiteRecruiting
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Module 1: AZD5863 Monotherapy Intravenous (IV)
Module 2: AZD5863 Monotherapy Subcutaneous (SC)
Module 1: AZD5863 Intravenous (IV) Monotherapy
Module 2: AZD5863 Subcutaneous (SC) Monotherapy