NL-OMON47345已完成不适用
An open-label, multicenter, dose escalation and expansion Phase Ib study to evaluate the safety, pharmacokinetics and therapeutic activity of RO6958688 in combination with atezolizumab in patients with locally advanced and/or metastatic CEA-positive solid tumors - WP29945 / CEA TCB
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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
- •- Confirmed locally advanced and/or metastatic solid tumor, with at least one tumor lesion of accessible non-critical location to biopsy, in patients who have progressed on a standard therapy, are intolerant to standard therapy, and/or are non-amenable to standard therapy.
- •- Radiologically measurable and clinically evaluable disease (as per RECIST v1.1 - previously irradiated lesions should not be counted as target lesions)
- •- Life expectancy of * 12 weeks and LDH levels <=<2.5 ULN
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0*1.
- •- All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade * 1 or returned to baseline except alopecia (any grade) and Grade 2 peripheral neuropathy
- •- Adequate haematological, liver and renal function
- •- Patients with non-colorectal cancer should have confirmed CEA expression in tumor or centrally confirmed CEA expression in tumor tissue. For CRC cancer patients, the CEA assessment should be performed, but result is not required for patient selection. If no archival tumor tissue is available, in this case fresh biopsy is collected.
排除标准
- •- Active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- •- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for * 2 weeks prior to enrolment
- •- Leptomeningeal disease
- •- Patients with paraspinal, paratracheal, and mediastinal pathological lesions larger than 2 cm unless they are previously irradiated.
- •- Malignancies within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
- •- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- •- Known history of autoimmune disease
- •- patients with bilateral lung lesions and dyspnea and/or SaO2<92% or patients with lobectomy or pneumonectomy with lung metastases in the remaining lung and either dyspnea or SaO2 <92% at baseline.
- •- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 28 days prior to Cycle 1 Day 1
- •- Regular immunosuppressive therapy
- •- Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
- •- Radiotherapy within the last 28 days before Cycle 1 Day 1 with the exception of limited field palliative radiotherapy for bone pain relief
- •See protocol for Obinutuzumab-specific exclusion criteria.
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