NL-OMON56657尚未招募不适用
A PHASE Ia/Ib, OPEN LABEL, MULTICENTER, DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF RO7502175 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS - GO43860 Study - IVDR
Genentech Inc. c/o F. Hoffmann-La Roche Ltd0 个研究点目标入组 62 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
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
- •- Age >= 18 years
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •- Life expectancy >= 12 weeks
- •- Adequate hematologic and end-organ function
- •- Histologically confirmed locally advanced, recurrent, or metastatic incurable
- •solid tumor malignancy
- •- Availability of representative tumor specimens
- •- Measurable disease per Response Evaluation Criteria in Solid Tumors Version
- •1.1 (RECIST v1.1)
- •- For women of childbearing potential: agreement to remain abstinent (refrain
- •from heterosexual intercourse) or use contraception, and agreement to refrain
- •from donating eggs
- •- For men: agreement to remain abstinent (refrain from heterosexual
- •intercourse) or use contraception, and agreement to refrain from donating sperm
排除标准
- •- Pregnant or breastfeeding, or intending to become pregnant during the study
- •or within 5 months after the final dose of study treatment
- •- Symptomatic, untreated, or actively progressing central nervous system (CNS)
- •- History of leptomeningeal disease
- •- Significant cardiovascular disease within 3 months prior to initiation of
- •study treatment
- •- History of malignancy other than disease under study within 3 years prior to
- •- Any immune-mediated adverse events related to prior cancer immunotherapy that
- •have not resolved completely to baseline
- •- Active or history of autoimmune disease or immune deficiency
- •- Active tuberculosis, hepatitis B or acute or chronic active EBV infection
- •- Positive test for human immunodeficiency virus (HIV) infection
- •- Positive hepatitis C virus (HCV) antibody test
- •- Known infection with severe acute respiratory syndrome coronavirus 2
- •(SARS-CoV-2)
- •- Major surgical procedure or significant traumatic injury within 28 days prior
- •to first study drug infusion
- •- Prior allogeneic stem cell or organ transplantation
研究者
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