A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 176
- 主要终点
- Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female subjects, age 18 years or older
- •Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
- •Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment
排除标准
- •Laboratory and medical history parameters not within protocol-defined range
- •Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
- •Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
- •Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
- •Has an active or inactive autoimmune process
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis
- •Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
- •Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
- •Currently pregnant or breastfeeding
研究组 & 干预措施
MEDI4736 + INCB024360
MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
干预措施: MEDI4736 (Drug)
MEDI4736 + INCB024360
MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
干预措施: INCB024360 (Drug)
结局指标
主要结局
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
时间窗: Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Measured every 8 weeks for duration of study treatment [approximately 12 months]
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
次要结局
- Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1(Measured every 8 weeks for duration of study treatment [approximately 6 months])
- Phase 2: Number of Treatment-Emergent Adverse Events(Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years])
- Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression(Measured every 8 weeks for duration of active study treatment [approximately 24 months])
- Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death(Measured every 8 weeks for duration of active study treatment [approximately 24 months])
- Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration(Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1)
- Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration(Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1)
- Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve(Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1)
- Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)(Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].)