JPRN-jRCT2080224802已完成1 期
A Phase 1b Study of INCMGA00012 (PD-1 Inhibitor), INCB001158 (Arginase Inhibitor), and the Combination in Japanese Participants With Advanced Solid Tumors
Incyte Biosciences Japan G.K.0 个研究点目标入组 18 人开始时间: 2019年7月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1 Participant is Japanese
- •2 Histologically or cytologically confirmed diagnosis of any locally advanced or metastatic solid tumors not amenable to local or other curative therapy.
- •3 Participants with nonevaluable lesions are allowed.
- •4 Life expectancy > 3 months.
- •5 Eastern Cooperative Oncology Group performance status 0 to 1.
- •6 Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
- •7 Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
- •8 Male participants should avoid unprotected sex with women of childbearing potential and refrain from donating sperm during participation the study.
排除标准
- •1 Receipt of anticancer therapy or participation in another interventional clinical study within 14 days before the first administration of study drug with the following exceptions: Immunotherapy or biological therapy (eg, monoclonal antibodies) within 21 days the first administration of study drug; 6 weeks for mitomycin-C or nitrosoureas; 7 days for tyrosine kinase inhibitors.
- •2 Radiotherapy within 14 days of first dose of study treatment with the following exceptions: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is > 30 Gy.
- •3 Toxicity of prior therapy and/or complications from surgical intervention that has not recovered to <- Grade 1 or baseline within 7 days before starting study drug treatment (with the exception of anemia not requiring transfusion support and any grade of alopecia). Note: Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
- •4 Receipt of prior systemic treatment with an arginase inhibitor
- •5 Immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy is recommended (per product label or consensus guidelines), OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well controlled on replacement hormones).
- •6 Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
- •7 Known active central nervous system metastases and/or carcinomatous meningitis.
- •8 Known active hepatitis A virus, hepatitis B virus, or hepatitis C virus infection.
- •9 Known HIV infection.
- •10 Active infections requiring systemic therapy.
- •11 Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures and/or known hypersensitivity >- Grade 3, or severe reaction, to study treatments or any of their excipients or additives.
- •12 Participants with impaired cardiac function or clinically significant cardiac disease.
- •13 Evidence of interstitial lung disease or active, noninfectious pneumonitis or a history of interstitial lung disease.
- •14 Participant is pregnant or breastfeeding.
研究者
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