NCT03589651已完成1 期
A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 9
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
- •Measurable or nonmeasurable tumor lesions per RECIST v 1.
- •Willing to provide fresh or archival tumor tissue for correlative studies.
- •Eastern Cooperative Oncology Group performance status 0 to
- •Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
排除标准
- •Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
- •Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
- •Laboratory values outside the protocol-defined range at screening.
- •Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
- •Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- •Evidence of interstitial lung disease or active, noninfectious pneumonitis.
研究组 & 干预措施
Group A
Experimental
INCMGA00012 with epacadostat.
干预措施: Retifanlimab (Drug)
Group A
Experimental
INCMGA00012 with epacadostat.
干预措施: Epacadostat (Drug)
Group B
Experimental
INCMGA00012 with INCB050465.
干预措施: Retifanlimab (Drug)
Group B
Experimental
INCMGA00012 with INCB050465.
干预措施: INCB050465 (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: Up to approximately 30 months
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
次要结局
- Duration of response(Up to approximately 30 months)
- Tmax of INCMGA00012 when given in combination with immune therapies(Up to approximately 4 months)
- Cmax of epacadostat when given in combination with INCMGA00012(Up to approximately 4 months)
- Overall survival(Up to approximately 30 months)
- Tmax of epacadostat when given in combination with INCMGA00012(Up to approximately 4 months)
- Cmax of INCB050645 when given in combination with INCMGA00012(Up to approximately 4 months)
- Overall response rate(Up to approximately 30 months)
- Cmax of INCMGA00012 when given in combination with immune therapies(Up to approximately 4 months)
- Tmax of INCB050645 when given in combination with INCMGA00012(Up to approximately 4 months)
- Progression-free survival(Up to approximately 30 months)
研究者
研究点 (9)
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