NL-OMON44807已完成不适用
AN OPEN-LABEL, MULTICENTER, DOSE ESCALATION PHASE IB STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND THERAPEUTIC ACTIVITY OF RO7009789 (CD40 AGONIST) IN COMBINATION WITH ATEZOLIZUMAB (ANTI-PD-L1) IN PATIENTS WITH LOCALLY ADVANCED AND/OR METASTATIC SOLID TUMORS - BP29392
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy
- •*Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •*Life expectancy * 16 weeks
- •*Adequate hematologic and end organ function
- •*Measurable disease per RECIST v1.1
- •*Patient*s ability to comply with the collection of tumor biopsies. Tumors must be accessible for biopsy.
- •*Consent to undergo pretreatment and/or on-treatment biopsies for PD biomarker analysis
排除标准
- •*Any approved anti-cancer therapy that includes chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to the first dose of study treatment
- •*Adverse events from prior anti-cancer therapy that have not resolved to Grade * 1 except for any grade alopecia and * Grade 2 peripheral neuropathy
- •*Bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed.
- •*Patients who are receiving denosumab prior to enrollment must be willing and eligible to receive a bisphosphonate while on study.
- •*Uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (one monthly or more frequently). Patients with indwelling catheters are allowed.
- •*Known clinically significant liver disease which includes active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
- •*History (within the previous year) of congestive heart failure, stroke, arrhythmia, or myocardial infarction
- •*History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1)
- •*Significant cardio- or cerebrovascular disease within 6 months prior to Cycle 1 Day 1
- •*Known hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand*s disease, cancer-associated diffuse intravascular coagulation)
- •*Clinically meaningful proteinuria
- •*Requiring dialysis (peritoneal or hemodialysis)
- •*Known primary CNS malignancy or symptomatic or untreated CNS metastases
- •*History of autoimmune diseases
研究者
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