CTIS2022-501234-37-00招募中1 期
A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination with Cemiplimab in Patients with Advanced Solid Tumors - R7075-ONC-2009
Regeneron Pharmaceuticals Inc.0 个研究点目标入组 565 人开始时间: 2023年5月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 565
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 65+（—）
- 性别
- All
入选标准
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol, Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PDL1) naïve, defined as never having previously been treated with a drug that targets the PD-1, Has at least 1 lesion that meets study criteria as defined in the protocol, Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated, Has adequate organ and bone marrow function as defined in the protocol, In the judgement of the investigator, has a life expectancy of at least 3 months
排除标准
- •Is currently participating in another study of a therapeutic agent, Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments as defined in the protocol, Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression, Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug, Has any ongoing inflammatory skin disease as defined in the protocol. NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply, Has participated in any study of an investigational agent or an investigational device within 4 weeks of the first administration of study drug as defined in the protocol, Has received treatment with an approved systemic therapy within 4 weeks of the first administration of study drug or has not yet recovered (ie, grade 1 or baseline) from any acute toxicities, Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as defined in the protocol, Has received radiation therapy or major surgery within 14 days of the first administration of study drug or has not recovered (ie, grade 1 or baseline) from adverse events, Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug., Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol, Has second malignancy that is progressing or requires active treatment as defined in the protocol, Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or antiinflammatory equivalent) within 1-2 weeks prior to the first dose of study drug as defined in the protocol
研究者
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