EUCTR2014-002835-32-FR进行中（未招募）1 期
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 MPDL3280A (ANTI-PD-L1) IN PATIENTS WITH LOCALLY ADVANCED AND/OR METASTATIC SOLID TUMORS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors, which are not amenable to standard therapy
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •- Life expectancy >/= 16 weeks
- •- Adequate hematologic and end organ function
- •- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •- Ability to comply with the collection of tumor biopsies; tumors must be accessible for biopsy
- •- Agreement to use effective methods of contraception per the protocol requirements; female patients of childbearing potential must have a negative pregnancy test (urine/serum) within seven days prior to the first study drug administration
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Diagnosis of non-small cell lung cancer (NSCLC) (excluded from Part I only)
- •- Any approved anti-cancer therapy that includes chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to the first dose of study treatment; the following is, allowed: Palliative radiotherapy for bone metastases - Adverse events from prior anti-cancer therapy that have not resolved to - Bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons allowed. Patients receiving denosumab prior to enrollment must be willing to receive a bisphosphonate while on study.
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (at least one monthly). 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
- •- Clinically meaningful proteinuria
- •- Requiring dialysis
- •- Known primary CNS malignancy or symptomatic or untreated CNS metastases: patients with asymptomatic-treated CNS metastases may be enrolled after consultation with the Medical Monitor, provided they meet the following criteria:
- •Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study
- •No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1 Day 1
- •- Allergy or hypersensitivity to components of the RO7009789 formulation or to components of MPDL3280A formulation
- •- History of autoimmune diseases
- •- History of idiopathic pulmonary fibrosis, pneumonitis (excluding infectious disease-induced), organizing pneumonia, or evidence of active pneumonitis. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •- Patients with HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection
- •- Active tuberculosis
- •- Severe infections within 4 weeks prior to Cycle 1 Day 1
- •- Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
- •- Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1. Patients receiving prophylactic antibiotics are eligible.
- •- Major surgical procedure within 28 days prior to Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study
- •- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study
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