NL-OMON56334招募中不适用
Phase I First Time in Human Open Label Study of GSK3745417 administered with and without Anticancer Agents in Participants with Advanced Solid Tumors (study 208850) - study 208850
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
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
- •Male or female, age 18 years and above.
- •Histologically or cytologically confirmed advanced/recurrent solid tumors,
- •who have progressed on, be intolerant of, or ineligible for, all available
- •therapies for which clinical benefit has been established.
- •Fresh tumor sample. For further details: see protocol section 5.1, item 5.
- •Measurable disease. For further details: see protocol section 5.1, item 6.
- •ECOG performance status 0-1.
- •Life expectancy of at least 12 weeks.
- •Adequate organ function. For further details: see protocol section 5.1, item
- •Not pregnant or breastfeeding females and females of non-reproductive
- •potential or reproductive potential and agrees to follow a required
- •contraceptive method. For further details: see protocol section 5.1, item 11.
排除标准
- •Malignancy other than disease under study. For further details: see protocol
- •section 5.2, item 1.
- •CNS metastases. For further details: see protocol section 5.2, item 2.
- •Active autoimmune disease that has required systemic treatment within the
- •last 2 years. Replacement therapy is not considered a form of systemic
- •treatment. For further details: see protocol section 5.2, item 3.
- •Concurrent medical condition requiring the use of systemic immunosuppressive
- •treatment within 28 days before the first dose of study treatment. For further
- •details: see protocol section 5.2, item 4.
- •Current unstable liver or biliary disease per investigator assessment. For
- •further details: see protocol section 5.2, item 5.
- •History of vasculitis.
- •Active infection requiring systemic therapy, known human immunodeficiency
- •virus infection, positive test for hepatitis B or hepatitis C. See protocol
- •section 5.2, item 8.
- •Within the past 6 months: acute diverticulitis, inflammatory bowel disease,
- •intra-abdominal abscess, or gastrointestinal obstruction.
- •Allergen desensitization therapy within 4 weeks of starting study treatment.
- •History or evidence of cardiac and pulmonary abnormalities. For further
- •details: see protocol section 5.2, item 12-15.
- •Within 6 months: uncontrolled symptomatic ascites or pleural or pericardial
- •Prior or concomitant therapies listed in protocol section 5.2, item 19-24.
- •Recent (within the past 6 months) history of any grade of immune myocarditis
- •or pericarditis.
研究者
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