Symbiotic-GI-16: A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAIVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

未提供0 个研究点目标入组 840 人开始时间: 待定

适应症

试验速览

暂无简介。

•Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.
•Evidence of locally advanced or metastatic disease.
•Eastern Cooperative Oncology Group performance status (ECOG) 0-1
•No prior systemic therapy for advanced or metastatic disease.
•Adequate hepatic, liver, and renal function
•HER-2 negative status
•PD-L1 positive status

•Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression
•Clinically significant risk of hemorrhage or fistula
•Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
•History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
•Any Grade >=3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
•Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
•Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
•Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis

发起方

未提供