NL-OMON47188已完成不适用
AN OPEN-LABEL, MULTICENTER, DOSE ESCALATION PHASE IB STUDY WITH EXPANSION COHORTS TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS AND THERAPEUTIC ACTIVITY OF RO7009789 (CD40 AGONISTIC MONOCLONAL ANTIBODY) OR BEVACIZUMAB (ANTI-VEGF MONOCLONAL ANTIBODY, PART II) IN COMBINATION WITH VANUCIZUMAB (ANTI-ANG2 AND ANTI-VEGF BI-SPECIFIC MONOCLONAL ANTIBODY) IN PATIENTS WITH METASTATIC SOLID TUMORS - Phase Ib combination with RO7009789 (CD40 agonist) and bevacizumab
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- •* Part I: Advanced/metastatic histologically confirmed solid tumor (except prostate cancer and squamous NSCLC) not amenable to standard therapy
- •* Part II: Histologically confirmed diagnosis of advanced/metastatic aPROC, HNSCC and non-squamous NSCLC previously treated with anti-PD-L1 inhibitor alone or in combination
- •* Age * 18 years
- •* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •* Life expectancy * 16 weeks
- •* Adequate hematologic and organ function
- •* Adequate cardiovascular function
- •* Measurable disease Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
排除标准
- •* Patients with prostate cancer or squamous NSCLC
- •* Patients who have received prior systemic anti-cancer treatment within the following time frames (see protocol for details)
- •* Treatment with compounds targeting VEGF or VEGF-R within 12 months prior to enrolment (Part II only)
- •* Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1
- •* Chronic daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
- •However, occasional use for the symptomatic relief of medical conditions (e.g.
- •headache) is allowed
- •* Patients who have undergone major surgery within 4 weeks prior to study drug administration
- •* Patients who have undurgone any abdominal surgery or interventions (including colonoscopy)or
- •significant abdominal traumatic injury within 60 days prior to Day 1 of
- •* Known clinically significant liver disease (with the exception of Gilbert's syndrome)
- •* History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1)
- •* History of hemoptysis (bronchopulmonary hemorrhage) NCI CTCAE * Grade 2 within 4 weeks prior to study drug administration;
- •* Metastatic disease that involves major airways or blood vessels, or centrally
- •located mediastinal tumor masses (< 30 mm from the carina) of large volume
- •* Significant cardio- or cerebrovascular disease within 6 months prior to Cycle 1 Day 1
- •* History of intra-abdominal inflammatory process within 6 months prior to
- •Day 1 Cycle 1, including but not limited to: diverticulitis, peptic ulcer disease,
- •* History of bowel obstruction and/or clinical signs or symptoms of
- •gastrointestinal obstruction including sub-occlusive disease, related to the
- •underlying disease or a requirement for routine parenteral hydration, parenteral
- •nutrition, or tube feeding. Patients with signs/symptoms of sub-/occlusive
- •syndrome/bowel obstruction at time of initial diagnosis may be enrolled if
- •they had received definitive (surgical) treatment for symptom resolution.
- •* Evidence of abdominal free air not explained by paracentesis or recent
- •surgical procedure
- •* Patients with colonic prosthesis (stent) implant in place (as applicable)
- •* Severe non-healing wound, active ulcer or untreated bone fracture
- •* Known primary CNS malignancy or symptomatic or untreated CNS metastases.
- •* Pregnancy, lactation, or breastfeeding
- •* History of autoimmune diseases
- •* Patient with HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection
- •* Severe infections within 4 weeks prior to Cycle 1 Day 1
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