NCT04272034终止1 期
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select 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
- 105
- 试验地点
- 24
- 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 evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select 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
- •Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
- •Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
- •ECOG performance status score of 0 or
- •Life expectancy > 12 weeks.
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Exclusion Criteria:
- •Laboratory values outside the Protocol-defined ranges.
- •Clinically significant cardiac disease.
- •History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.
- •Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
- •Known additional malignancy that is progressing or requires active treatment.
- •Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
- •Prior receipt of an anti-PD-L1 therapy.
- •Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- •A 28-day washout for systemic antibiotics is required.
- •Probiotic usage while on study and during screening is prohibited.
- •Active infection requiring systemic therapy.
- •Known history of HIV
- •Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
研究组 & 干预措施
Cohort 1
Experimental
Participants with select solid tumors who are immunotherapy treatment-naive
干预措施: INCB099318 (Drug)
Cohort 2
Experimental
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
干预措施: INCB099318 (Drug)
Cohort 3
Experimental
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
干预措施: INCB099318 (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: Up to approximately 25 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 up to 30 days after last dose of study drug.
次要结局
- Cmin of INCB099318(Up to approximately 3 months)
- AUC0-t of INCB099318(Up to approximately 3 months)
- t½ of INCB099318(Up to approximately 3 months)
- λz of INCB099318(Up to approximately 3 months)
- Cmax of INCB099318(Up to approximately 3 months)
- tmax of INCB099318(Up to approximately 3 months)
- CL/F of INCB099318(Up to approximately 3 months)
- Vz/F of INCB099318(Up to approximately 3 months)
研究者
研究点 (24)
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