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.
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)
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
Sequential
AZD5863
DrugT cell-engaging bi-specific antibody that targets CLDN18.2 (Claudin18.2) on tumor cells and CD3 on T cells
AZD2936
DrugRilvegostomig is a bi-specific antibody targeting the immunosuppressive PD-1 and TIGIT pathways.
The number of patients with adverse events
Number of patients with adverse events by system organ class and preferred term
The number of patients with adverse events of special interest
Number of patients with adverse events of special interest by system organ class and preferred term
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation.
The number of patients with serious adverse events
Number of patients with serious adverse events by system organ class and preferred term
Objective Response Rate (ORR)
The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose escalation only.
Disease Control Rate (DCR)
Percentage of patients with confirmed complete or partial response or having stable disease maintained for \>= 11 weeks from first dose, according to response criteria in solid tumours (RECIST 1.1).
Duration of response (DoR)
The time from the date of first response until date of disease progression or death in the absence of disease progression, according to response criteria in solid tumours (RECIST 1.1).
Progression free Survival (PFS)
The time from the start of study treatment/date of randomization until RECIST 1.1 defined disease progression or death in the absence of disease progression.
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