NCT03762447已完成1 期
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 25
- 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, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.
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
- •Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1 or RANO for primary brain tumors that are considered nonamenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable per RECIST v1.1 if progression has been demonstrated in the lesion.
- •Willingness to undergo a tumor biopsy to obtain tumor tissue,Pretreatment and on-treatment tumor biopsies are required.
- •Must have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to or ineligible for standard treatment. There is no limit to the number of prior treatment regimens.
- •Eastern Cooperative Oncology Group performance status score of 0 or
- •Life expectancy > 12 weeks.
- •Willingness to avoid pregnancy or fathering children.
- •Part 2 Expansion Cohort 2-A only: Participants with any type of solid tumor that has a local regulatory approval for an anti-PD-1 therapy. Other tumor types may be enrolled with medical monitor approval. Participants must have had confirmed disease progression on a prior anti-PD-1 monoclonal antibody.
- •Part 2 Expansion Cohort 2-B only: Participants with select solid tumors who are immunotherapy-naïve.
- •Part 3 MSI-H or dMMR Expansion Cohort only (Enrolled ex-United States only): Participants with any MSI-H or dMMR solid tumor who are immunotherapy-naïve.
- •Part 4 HPV-driven expansion cohort only: Participants with any HPV-positive solid tumor who have received prior standard therapy.
- •Note: HPV-positive status determined by a local laboratory using p16 IHC, polymerase chain reaction methods, or other locally-available method to detect HPV
排除标准
- •Laboratory values not within the Protocol-defined range.
- •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. Participants who have previously treated and clinically stable brain or CNS metastases and have not required steroids for at least 7 days before study treatment are eligible.
- •Known additional malignancy that is progressing or requires active treatment.
- •Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
- •Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- •Active infection requiring systemic therapy.
- •Active HBV or HCV infection that requires treatment.
- •Known history of HIV (HIV 1/2 antibodies).
- •Known hypersensitivity or severe reaction to any component of study drug or formulation components.
- •Prior receipt of an anti-PD-L1 therapy for all participants.
- •Presence of a gastrointestinal condition that may affect drug absorption.
研究组 & 干预措施
INCB086550
Experimental
干预措施: INCB086550 (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: Baseline through 90 days after end of treatment, estimated up to 12 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
- AUC0-tau of INCB086550 in fasted and food effect conditions(Approximately 1 month)
- Vz/F of INCB086550(Approximately 1 month)
- tmax of INCB086550 in fasted and food effect conditions(Approximately 1 month)
- Disease control rate(Every 8 weeks for the duration of study participation; estimated to be 12 months.)
- Cmax of INCB086550 in fasted and food effect conditions(Approximately 1 month)
- Objective response rate(Every 8 weeks for the duration of study participation; estimated to be 12 months.)
- AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions(Approximately 1 month)
- t½ of INCB086550(Approximately 1 month)
- λz of INCB086550(Approximately 1 month)
- CL/F of INCB086550(Approximately 1 month)
- Pharmacokinetic/pharmacodynamics correlation(Approximately 1 month)
- Cmin of INCB086550 in fasted and food effect conditions(Approximately 1 month)
- Duration of response(Every 8 weeks for the duration of study participation; estimated to be 12 months.)
研究者
研究点 (25)
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