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. - D9750C00001

AstraZeneca AB0 个研究点目标入组 200 人开始时间: 2023年7月7日最近更新: 2024年7月22日

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•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 RECIST v1.1, Must show positive CLDN18.2 expression in tumor cells as determined by central 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

•Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade = 2 except for those defined by the protocol, Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS), Participant experienced unacceptable CRS or ICANS following prior TCE or CAR-T cell therapy, Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment, CNS metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent, Infectious disease including active 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, Participant requires chronic immunosuppressive therapy, Participants on anticoagulation therapy

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