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INCB099280联合阿西替尼治疗成人晚期实体瘤的研究

2026年5月8日 更新者：Incyte Corporation

INCB099280 联合阿西替尼治疗成人晚期实体瘤的 1/2 期研究

本研究旨在评估 INCB099280 与阿西替尼联合用药的安全性和耐受性，并评估 INCB099280 与阿西替尼联合用药的抗肿瘤活性。

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

5

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 英国
      • Cambridge、英国、CB2 0QQ
        • Addenbrookes Hospital
      • Glasgow、英国、G12 0YN
        • Beatson West of Scotland Cancer Centrewester
      • London、英国、SE1 9RT
        • Guys Hospital
      • London、英国、EC1A 7BE
        • St Bartholomew's Hospital
      • London、英国、SW3 6JJ
        • The Royal Marsden
      • Sutton、英国、SM2 5PT
        • The Royal Marsden Nhs Foundation Trust - Sutton

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 根据实体瘤反应评估标准 1.1 版 (RECIST v1.1) 具有可测量病变的组织学证实的晚期实体瘤（方案定义的选择实体瘤），被认为不适合手术或其他治疗或程序。
  • 必须在接受至少一种既往全身化疗治疗期间或治疗后出现疾病进展。
  • 东部肿瘤合作组表现状态评分为 0 或 1。
  • 预期寿命 > 12 周。
  • 愿意避免怀孕。

排除标准：

  • 已知的其他恶性肿瘤正在进展或需要积极治疗。
  • 需要治疗的中枢神经系统 (CNS) 转移和/或软脑膜疾病。
  • 先前治疗的毒性尚未恢复至方案规定的限度。
  • 事先接受过抗 PD-1、抗 PD-L1 或抗 PD-L2 药物；使用免疫调节剂（例如 CTLA-4、GITR、LAG3、TIM3、OX40、ICOS、IL-2、4-1BB、CAR-T 细胞）治疗。
  • 既往使用针对 VEGF 通路的抗血管生成小分子 TKI 进行治疗
  • 在接受INCB099280的同时参加另一项介入性临床研究。
  • 心脏功能受损或有临床意义的心脏病。
  • 间质性肺疾病（包括非感染性肺炎）的病史或证据。
  • 存在可能影响药物吸收的胃肠道疾病。
  • 过去5年内任何需要全身治疗的自身免疫性疾病。
  • 诊断为原发性免疫缺陷或接受慢性全身类固醇治疗，每日剂量超过 10 毫克泼尼松或同等剂量。
  • 活动性感染需要全身治疗。
  • 器官移植史，包括干细胞移植。
  • 在第一剂研究治疗后 28 天内接受全身抗生素。
  • 在筛选期间和整个研究治疗期间禁止使用益生菌。
  • 在计划开始研究药物后 28 天内接种了活疫苗。
  • 实验室值超出协议定义的范围。
  • 器官功能不足。

其他协议定义的包含/排除标准可能适用。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：第 1 部分：剂量递增
将评估每日两次 (BID) 与阿西替尼 BID 联合给药的最多 6 剂 INCB099280，以确定剂量，以便在研究的剂量扩展阶段进一步评估。
药品：INCB099280
按照治疗臂说明中的规定给药
药品：阿西替尼
按照治疗臂说明中的规定进行给药
实验性的：第 2 部分：剂量扩展
完成第 1 部分后，参与者将被纳入 2 个特定疾病队列中的 1 个： 第 1 组：患有透明细胞妇科癌症的成人，其组织学至少有 50% 为透明细胞，且其疾病在至少 1 条既往治疗线中或之后出现进展。全身化疗，不适合根治性手术或（化学）放射治疗。 第 2 组：患有妇科罕见组织学亚型上皮癌的成人，其疾病在至少 1 种既往全身化疗期间或之后出现进展，并且不适合根治性手术或（化疗）放射治疗。 可以从第 1 部分中为第 2 部分扩展中的每个队列选择一剂或两剂。
药品：INCB099280
按照治疗臂说明中的规定给药
药品：阿西替尼
按照治疗臂说明中的规定进行给药

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
大体时间：up to 3 weeks
Any adverse event that ws at least possibly related to study treatment and met protocol-specified criteria was classified as a DLT. For the purpose of dose finding, decisions on dose were based on DLTs observed during the first 21 days of treatment.
up to 3 weeks
Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
大体时间：up to approximately 1 year
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to approximately 1 year
Part 1: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
大体时间：up to approximately 1 year
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to approximately 1 year
Part 2: Objective Response
大体时间：up to 2 years
Objective response was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to 2 years

次要结果测量

结果测量
措施说明
大体时间
Part 2: Number of Participants With Any TEAE
大体时间：up to 2 years
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to 2 years
Part 2: Number of Participants With TEAEs Leading to a Dosing Modification (Treatment Interruption, Dose Reduction, and Permanent Discontinuation of Either Study Drug)
大体时间：up to 2 years
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE therefore could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was either reported for the first time or the worsening of a pre-existing event after the first dose of either study drug until 104 days after the last dose of study treatment or the start of new anticancer therapy.
up to 2 years
Part 1: Objective Response
大体时间：up to 335 days
Objective response was defined as the percentage of participants with a BOR of CR or PR by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to 335 days
Part 1: Disease Control
大体时间：up to 335 days
Disease control was defined as the percentage of participants with a BOR of CR, PR, or stable disease (SD) by investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
up to 335 days
Part 1: Duration of Response (DOR)
大体时间：up to 335 days
DOR was defined as the time from the first CR or PR until disease progression by investigator assessment per RECIST v1.1 or death from any cause, whichever occurred earlier. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.
up to 335 days
Part 1: INCB099280 and Axitinib Plasma Concentrations
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Blood samples were collected for the analysis of INCB099280 and axitinib concentrations. Per Protocol, PK samples for axitinib were only to be analyzed in case of a concern that axitinib was not as active as expected. Due to the early termination of the study before readout, these samples were not analyzed.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Cmax of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Cmax was defined as the maximum observed concentration of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Tmax of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
tmax was defined as the time to the maximum concentration of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: AUC0-4h of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
AUC0-4h was defined as area under the steady-state plasma or serum concentration-time curve from 0 to 4 hours.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Cmax,ss of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Cmax,ss was defined as the maximum observed concentration at steady state.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Tmax,ss of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
tmax,ss was defined as the time to the maximum concentration of INCB099280 at steady state.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: AUC0-12h of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
AUC0-12h was defined as the area under the steady-state plasma or serum concentration-time curve from 0 to 12 hours.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Cavg of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Cavg was defined as the average concentration of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Ctau of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Ctau was defined as the concentration of INCB099280 at the end of a dose interval.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: t1/2 of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
t1/2 was defined as the apparent terminal-phase disposition half life of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: CLss/F of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
CLss/F was defined as the apparent oral dose clearance of INCB099280 at steady state.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Part 1: Vz/F of INCB099280 When Administered With Axitinib
大体时间：Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample
Vz/F was defined as the apparent oral dose volume of distribution of INCB099280.
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 8 Day 1: before INCB099280 and axitinib dose. Cycle 1 Day 1 and Cycle 2 Day 1: 1, 2, and 4 hours after INCB099280 dose. End-of-trial visit: axitinib sample

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Incyte Corporation

调查人员

  • 研究主任：Philomena Colucci、Incyte Corporation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年4月16日

初级完成 (实际的)

2025年6月6日

研究完成 (实际的)

2025年6月6日

研究注册日期

首次提交

2023年7月10日

首先提交符合 QC 标准的

2023年7月10日

首次发布 (实际的)

2023年7月18日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • INCB99280-201
  • 2022-003663-13 (EudraCT编号：CTIS (EU))
  • 2023-510281-27-00 (注册表标识符：EU CT Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

提交研究提案后，Incyte 会与合格的外部研究人员共享数据。 这些请求由审查小组根据科学价值进行审查和批准。 提供的所有数据均经过匿名处理，以根据适用的法律法规尊重参与试验的患者的隐私。 试验数据的可用性根据 https://www.incyte.com/our-company/compliance-and-transparency 中描述的标准和流程进行

IPD 共享时间框架

数据将在首次发表后或市场授权产品和适应症研究结束后 2 年后共享。

IPD 共享访问标准

合格研究的数据将根据 www.incyteclinicaltrials.com 数据共享部分中描述的标准和流程与合格的研究人员共享 网站。 对于获得批准的请求，研究人员将有权根据数据共享协议的条款访问匿名数据。

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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