An official website of the United States government
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Trial Status: active
This research is designed to determine if experimental treatment with AZD5863, a T
cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe,
tolerable and has anti-cancer activity in patients with advanced solid tumors.
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
Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
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 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 scheduled first dose of study intervention
Participants on anticoagulation therapy with long-acting anticoagulants or other class of anticoagulants at therapeutic doses Module 3 - Active or ongoing interstitial lung disease / pneumonitis, serious chronic gastrointestinal conditions Module 3 - Any of the following cardiac conditions as determined by investigator: Complex ventricular arrhythmia, symptomatic heart failure, Cardiomyopathy, myocardial infarction or unstable angina (within past 6 months) and uncontrolled hypertension. Module 3 - Known allergy or hypersensitivity to rilvegostomig or its excipients Module 3
Prior exposure to an anti-TIGIT therapy
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06005493.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
This is a first-time in human, modular Phase I/II, open-label multicentre study of
AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy
administered subcutaneously (Module 2) in patients with advanced or metastatic solid
tumors, or AZD5863 in combination with Rilvegostomig (Module 3). Each module contains
dose-escalation (Part A) and dose-expansion (Part B).