ISRCTN62420110已完成1 期
An open-label, multicenter, dose-escalation Phase Ib study to investigate the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of selicrelumab (CD40 agonist) in combination with atezolizumab (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
- 已完成
- 入组人数
- 140
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
- 性别
- All
入选标准
- •1. Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors, which are not amenable to standard therapy:
- •Part I: histologically confirmed diagnosis of advanced/metastatic small and large bowel carcinomas (small bowel and CRC), CPI-experienced non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC)
- •Part II: CPI-experienced NSCLC patients must have experienced documented disease progression on or after PD-L1 or PD-1 inhibitor therapy (investigational or approved): screening tumor assessment should confirm prior progression
- •2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •3. Life expectancy greater than or equal to 16 weeks
- •4. Adequate hematologic and end organ function
- •5. Measurable disease per RECIST Version 1.1
- •6. Ability to comply with the protocol requirements
- •7. Female participants of childbearing potential must have a negative pregnancy test (urine/serum) within seven days prior to the first study drug administration
- •8. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 5 months after the last dose of study treatment
- •9. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 28 days after the last dose of study treatment
排除标准
- •1. If one of the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1 Day 1) are: soluble interleukin 2 receptor (sCD25) greater than (>) 2 × upper limit of normal (ULN); Serum ferritin >1000 ng/ml
- •2. 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, however, allowed: Palliative radiotherapy for bone metastases less than or equal to ( 3. Adverse events from prior anti-cancer therapy that have not resolved to Grade 4. Bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (example: bone metastasis or osteoporosis) is allowed
- •5. Uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (one monthly or more frequently). Participants with indwelling catheters are allowed
- •6. Known clinically significant liver disease which includes active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
- •7. History (within the previous year) of congestive heart failure, stroke, arrhythmia, or myocardial infarction
- •8. History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1)
- •9. Significant cardio- or cerebrovascular disease within 6 months prior to Cycle 1 Day 1
- •10. Known hereditary or acquired coagulopathies
- •11. Clinically meaningful proteinuria
- •12. Requiring dialysis (peritoneal or hemodialysis)
- •13. Known primary central nervous system (CNS) malignancy or symptomatic or untreated CNS metastases: participants with asymptomatic-treated CNS metastases may be enrolled after consultation with the Medical Monitor, provided they meet the following criteria:
- •13.1. Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- •13.2. No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1 Day 1
- •14. Pregnancy, lactation, or breastfeeding
- •15. Allergy or hypersensitivity to components of the RO7009789 formulation or to components of atezolizumab formulation
- •16. History of autoimmune diseases (participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible; participants with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study)
- •17. History of idiopathic pulmonary fibrosis, pneumonitis (excluding infectious disease-induced), organizing pneumonia, or evidence of active pneumonitis
- •18. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •19. Participants with human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection
- •20. Active tuberculosis
- •21. Severe infections within 4 weeks prior to Cycle 1 Day 1
研究者
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