NCT03361228终止1 期
An Open-Label, Multicenter, Nonrandomized, Dose-Escalation, and Tumor-Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat (INCB024360), With or Without Pembrolizumab, in Subjects 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
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab
研究概览
简要总结
The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.
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
- •For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable).
- •For Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC.
- •Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Subjects with ≤ Grade 2 neuropathy are an exception and may enroll.
- •Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ≤ 7 days before treatment initiation.
排除标准
- •Participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose.
- •Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
- •Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
- •Prior therapy with an IDO1 or arginase 1 inhibitor.
- •Active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •Receipt of a live vaccine within 30 days before the first dose of study treatment.
- •Any history of serotonin syndrome after receiving serotonergic drugs.
- •Use of protocol-defined prior/concomitant therapy.
- •Known or suspected defect in the function of the urea cycle.
- •History of gastrointestinal condition that may affect drug absorption.
研究组 & 干预措施
INCB001158 + Epacadostat + Pembrolizumab
Experimental
干预措施: INCB001158 (Drug)
INCB001158 + Epacadostat + Pembrolizumab
Experimental
干预措施: Epacadostat (Drug)
INCB001158 + Epacadostat + Pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
INCB001158 + Epacadostat
Experimental
干预措施: INCB001158 (Drug)
INCB001158 + Epacadostat
Experimental
干预措施: Epacadostat (Drug)
结局指标
主要结局
Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab
时间窗: Up to approximately 12 months per subject
Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)
时间窗: Up to approximately 12 months per subject
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
次要结局
- Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE(Up to approximately 12 months per subject)
- Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab(Up to approximately 12 months per subject)
- Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab(Up to approximately 12 months per subject)
- Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab(Up to approximately 12 months per subject)
- Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab(Up to approximately 12 months per subject)
- Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat(Up to approximately 1 month)
研究者
研究点 (2)
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