NL-OMON46970已完成不适用
AN OPEN-LABEL, MULTICENTER, DOSE ESCALATION, PHASE IA/IB STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE CONSISTING OF INTERLEUKIN 2 VARIANT (IL-2v) TARGETING FIBROBLAST ACTIVATION PROTEIN-* (FAP), AS A SINGLE AGENT (PART A) OR IN COMBINATION WITH TRASTUZUMAB OR CETUXIMAB - BP29842 / FAP-IL2v
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- •- Radiologically measurable and clinically evaluable disease
- •- Life expectancy of 12 weeks
- •- Confirmed at least one tumor lesion with location accessible to safely biopsy per
- •clinical judgment of the treating physician and the participant*s consented
- •willingness to undergo baseline and on-treatment tumor biopsies for PD
- •biomarker analysis
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •- Patients with unilateral pleural effusion (other than non-small cell lung cancer [NSCLC] indication) should fulfill Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification 0-1 level and New York Health Association (NYHA) classification class 1 criteria for pulmonary and cardiac functions
- •- Adequate cardiovascular, hematological, liver and renal function
- •- 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
- •- Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women 12 months 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 4 months after the last dose of study drug for RO6874281, and for at least 7 months after the last dose of trastuzumab. For cetuximab, please refer to local prescribing information for cetuximab
- •- For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least for at least 2 months after the last dose of study drug or study treatment;
- •- Patients with Gilbert*s syndrome will be eligible for the study;
- •- For Part A exclusively (RO6874281 monotherapy), confirmed advanced and/or metastatic solid tumor, with at least one tumor lesion of location accessible to biopsy per clinical judgment of the treating physician, and confirmed progression at baseline; for whom no effective standard therapy that would confer clinical benefit to the patient exists
- •- For Part B exclusively (RO6874281 in combination with trastuzumab), patients with metastatic or recurrent or locally advanced HER2-positive breast cancer, as defined by the College of American Pathologist HER2 testing guidelines, who have progressed on at least two lines of HER2-directed therapies in the metastatic setting and the last therapy prior to going on study has to contain a HER2-directed antibody.
- •- Baseline LVEF of ><= 50% (measured by echocardiography) predose on Cycle 1 Day 1
- •- For Part C exclusively (RO6874281 in combination with cetuximab), Patients with recurrent, unresectable or metastatic squamous cell carcinoma of the head and neck. Patients can have had standard or experimental treatment, including but not limited to radiation therapy, chemotherapy, immunotherapies (excluding IL-2 compounds).
排除标准
- •Absence of rapid disease progression or threat to vital organs or critical anatomical sites (e.g., respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention.
- •* Symptomatic or untreated CNS metastases.
- •* History of treated asymptomatic CNS metastases with any of the following criteria:
- •o Metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
- •o History of intracranial hemorrhage or spinal cord hemorrhage
- •o Lacking radiographic demonstration of improvement upon the completion of CNS-directed therapy and evidence of interim progression between the completion of CNS-directed therapy and the baseline radiographic study
- •o Ongoing requirement for dexamethasone as therapy for CNS disease; anticonvulsants at a stable dosage are allowed
- •o Stereotactic radiation or whole-brain radiation within 28 days before study treatment administration
- •o Last CNS radiographic study < 4 weeks since completion of radiotherapy and < 2 weeks since discontinuation of corticosteroids
- •o CNS metastases treated by neurosurgical resection or brain biopsy performed within 28 days before study treatment administration
- •- Patients with an active second malignancy
- •- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, and known autoimmune diseases or other disease with ongoing fibrosis
- •- Patients (all indications) with confirmed bilateral pleural effusion and NSCLC patients with confirmed uni-or bilateral pleural effusion by X-ray are not eligible
- •- Significant cardiovascular/cerebrovascular vascular disease within 6 months prior to Day 1 of study drug administration
- •- Active or uncontrolled infections
- •- Known HIV, HBV, or hepatitis C (HCV) virus infection
- •- Positive serology for hepatitis B (only for Parts B and C)
- •- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks prior to the start of drug administration
- •- History of chronic liver disease or evidence of hepatic cirrhosis
- •- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- •- Major surgery or significant traumatic injury < 28 days prior to the first RO6874281 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
- •- Dementia or altered mental status that would prohibit informed consent
- •- Pregnant or breastfeeding women
- •- Known hypersensitivity to any of the components of RO6874281
- •- Concurrent therapy with any other investigational drug
- •- Immunomodulating agents
- •- Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited field palliative radiotherapy
- •- History of progressive multifocal leukoencephalopathy
- •- Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
- •- For Part B, exclusively, known hypersensitivity to any of the components of trastuzum
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