ISRCTN16358704已完成1 期
An open-label, multicenter, dose-escalation and expansion Phase Ib study to evaluate the safety, pharmacokinetics, and therapeutic activity of cibisatamab in combination with atezolizumab in patients with locally advanced and/or metastatic CEA-positive solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 228
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. Confirmed locally advanced and/or metastatic solid tumor, with at least one tumor lesion of accessible non-critical location to biopsy, in participants who have progressed on a standard therapy, are intolerant to standard therapy, and/or are non-amenable to standard therapy
- •2. Radiologically measurable and clinically evaluable disease (as per RECIST v1.1)
- •3. Life expectancy (in the opinion of the investigator) of at least 12 weeks and lactate dehydrogenase (LDH) levels 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
- •5. All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade 6. Adequate hematological, liver, and renal function
- •7. Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women 8. Participants must agree to remain abstinent or be willing to use effective methods of contraception as defined in the protocol
- •9. Participants with non-colorectal cancer should have confirmed CEA expression in tumor tissue. For colorectal cancer (CRC), the CEA assessment should be performed but the result is not required for participant selection
排除标准
- •1. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- •2. 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 at least 2 weeks prior to enrollment
- •3. Leptomeningeal disease
- •4. Participants with paraspinal, paratracheal, and mediastinal pathological lesions larger than 2 cm unless they are previously irradiated
- •5. 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
- •6. Significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results
- •7. Uncontrolled hypertension, unstable angina, congestive heart failure (CHF), serious cardiac arrhythmia requiring treatment history of myocardial infarction within 6 months of enrollment
- •8. Administration of a live, attenuated vaccine within 28 days before Cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- •9. Human Immunodeficiency Virus (HIV), active Hepatitis B or Hepatitis C (HCV)
- •10. Severe infections within 28 days prior to Cycle 1 Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia or active tuberculosis
- •11. Received oral or intravenous (IV) antibiotics within 14 days prior to Day 1
- •12. 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
- •13. Major surgery or significant traumatic injury less than 28 days prior to Cycle 1 Day 1 (excluding biopsies) or anticipation of the need for major surgery during study treatment
- •14. Known history of autoimmune disease as defined in the protocol
- •15. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis (including drug induced) on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- •16. Participants with bilateral lung lesions and dyspnea and/or oxygen saturation level (SaO2) less than 92% (at rest, room air and exertion) or participants with lobectomy or pneumonectomy with lung metastases in the remaining lung and either dyspnea or SaO2 less than 92% (at rest, room air and exertion) at baseline
- •17. Pregnant or breastfeeding
- •18. Known hypersensitivity to any of the components of cibisatamab and atezolizumab; hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •19. Investigational therapy (defined as treatment for which there is no regulatory authority approved indication) or last dose of prior immunotherapies within 28 days prior to Cycle 1 Day 1. Participants previously treated with anti-p
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