Tests AZD5863 in adults with advanced stomach, pancreatic or esophageal cancer

Trial details

Who runs it

AstraZeneca

Trial code

NCT06005493EU 2023-504139-42-00

Record updated

25 September 2026

Original description

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.Read full original descriptionShow less

A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors

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: 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.

Exclusion: 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; 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 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; 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.

ClinicalTrials.gov NCT06005493 · EU CTIS 2023-504139-42-00