NL-OMON46963已完成不适用
A phase 1b, open-label, multi-center, dose-escalation study of the safety, pharmacokinetics and therapeutic activity of cergutuzumab amunaleukin, an immunocytokine, which consists of a variant of interleukin-2 (IL2v) targeting carcinoembryonic antigen (CEA), and atezolizumab, an antibody that targets programmed death ligand 1 (anti-PDL1) administered intravenously, in patients with locally advanced and/or metastatic solid tumors - BP29435
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 64（—）
入选标准
- •Adult patients, * 18 years of age;* Confirmed locally advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy (with exception to NSCLC patients), and with confirmed progression at baseline that has progressed on, or patient is intolerant to, the standard of care therapy;* Radiologically measurable and clinically evaluable disease (as per response evaluation criteria in Solid Tumors [RECIST] v1.1) ;* Life expectancy, in the opinion of the investigator, of * 12 weeks;* 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, except alopecia (any grade) and Grade 2 peripheral neuropathy;* Adequate hematological, liver and renal function test results;* Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women <<= 2 years after menopause.;* For women who are not postmenopausal and have not undergone surgical sterilization agreement to remain abstinent or use two adequate non-hormonal methods of contraception, including at least one method with a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, and at least four months after the last dose of cergutuzumab amunaleukin, whichever is the longest.;*For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 2 months after the last dose of cergutuzumab amunaleukin. Men must refrain from donating sperm during this same period;* Locally or centrally confirmed CEA expression in archival tumor tissue (><=20% of tumor cells staining with at least moderate intensity). If no archival tumor tissue is available the fresh biopsy is collected for centrally confirmed CEA expression;* Patients with unilateral pleural effusion (other than lung cancer indication) should fulfill the following criteria for pulmonary and cardiac functions as: GOLD classification 0-1 level and NYHA classification class 1.;*Gilbert*s syndrome: Patients with Gilbert*s syndrome will be eligible for the study. The diagnosis of Gilbert*s syndrome is suspected in people who have persistent, slightly elevated levels of unconjugated bilirubin without any other apparent cause
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 enrollment.
- •* Leptomeningeal disease;* Patients with an active second malignancy . Patients who have a history of malignancy are not considered to have an active malignancy if they have completed therapy and are considered by their treating physician to be at <=30% risk for relapse.;* Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases
- •* Patients (all indications) with bilateral pleural effusion and lung cancer patients with unilateral of bilateral effusion confirmed at screening by X-ray;* Uncontrolled hypertension, unstable angina, congestive heart failure (CHF) New York Heart Association (NYHA) classification stage >2, serious cardiac arrhythmia requiring treatment (except for patients with pleural effusion, who should have NYHA =<1 serious cardiac arrhythmia requiring treatment, history of myocardial infarction within 6 months of enrollment)
- •*Administration of a live, attenuated vaccine within 4 weeks before cycle 1 day 1 or anticipated that such a live attenuated vaccine will be required during the study or 5 months after the last dose atezolizumab.
- •* Known HIV or Active HBV or HCV infection, patients with past or resolved hepatitis B are eligible.
- •*Severe infections within 4 weeks prior to cycle 1 day 1.
- •*Received oral of intravenous antibiotics within 2 weeks prior to cycle 1 day 1. Patients receiving prophylactic antibiotics are eligible.;* 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
- •*Major surgery of significant traumatic injury <28 days prior to Cycle 1 Day 1 or anticipation of the need for major surgery during study treatment.
- •*Dementia or altered mental status that would prohibit informed consent.
- •* History or risk of autoimmune disease,
- •*History of idiopathic pulmonary firbrosis, pneumonitis organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted
- •* Baseline QTc interval of >470 ms, baseline resting bradycardia <45 beats per minute, or baseline resting tachycardia > 100 beats per minute.
- •*Pregnant or breast-feeding women.;* Known hypersensitivity to any of the components of, cergutuzumab amunaleukin en atezolizumab, hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
- •*Investigational therapy (defined as treatment for which there is no regulatory authority approved indication) within 28 days prior to Cycle 1 Day 1.
- •*Last dose with any of the following agents including but not limited to: etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab <28 dyas prior to Cycle 1 Day 1.;* Last dose of prior immunotherapies including but not limited to: interferon alpha (IFN-a), int
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