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.

Advanced or metastatic solid tumors

Dose Escalation: Incidence of AEs, AESIs, DLTs and SAEs, Dose Escalation: AEs leading to discontinuation of AZD5863, Dose Escalation: Assess clinically significant alterations in vital signs and abnormal laboratory parameters, Dose Expansion: Incidence of AEs, AESIs and SAEs, Dose Expansion: AEs leading to discontinuation of AZD5863, Dose Expansion: Assess clinically significant alterations in vital signs and abnormal laboratory parameters, Dose Expansion: According to RECIST v1.1: ORR

Dose Escalation: According to RECIST v1.1: ORR, Dose Escalation and Dose Expansion: According to RECIST v1.1: DCR, DoR, PFS, Dose Escalation and Dose Expansion: Overall Survival, Dose Escalation and Dose Expansion: Serum concentrations of AZD5863, Dose Escalation and Dose Expansion: Serum PK parameters of AZD5863, including but not limited to Cmax, AUC, clearance and t1/2, as data allow, Dose Escalation and Dose Expansion: The number and percentage of participants who develop ADAs measured in serum, Dose Escalation and Dose Expansion: To investigate CLDN18.2 expression in tumour cells in relation to response to AZD5863

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France, Netherlands