Phase I/II Study of AZD5863 in Adult Participants with Advanced or Metastatic Solid Tumors

Hibi Kazushige0 个研究点目标入组 200 人开始时间: 2023年7月1日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•Age 18 or more 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 or more
•- 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 or more except for those defined by the protocol
•- 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 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

发起方

Hibi Kazushige