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Vodobatinib (K0706) 治疗难治性/不耐受 CML 的安全性和抗白血病活性≥3 种既往 CML 疗法失败

2026年4月21日 更新者：Sun Pharma Advanced Research Company Limited

一项由两部分组成的 1/2 期研究，旨在确定 K0706（一种新型酪氨酸激酶抑制剂 (TKI)）在健康受试者和慢性粒细胞白血病 (CML) 或费城染色体阳性急性淋巴细胞患者中的安全性、耐受性、药代动力学和活性白血病 (Ph+ ALL)

确定 Vodobatinib (K0706) 在治疗难治性/不耐受性 CML 中的安全性、耐受性、药代动力学和抗白血病活性的 1/2 期研究

研究概览

地位

终止

条件

干预/治疗

详细说明

研究的 A 部分（针对健康志愿者）已完成

B 部分剂量递增研究已完成。 印度和韩国正在进行剂量扩展招募

治疗难治性/不耐受性受试者的 C 部分研究正在全球范围内招募。

研究类型

介入性

注册 (实际的)

124

阶段

  • 阶段2
  • 阶段1

扩展访问

暂时不可用 查看扩展访问记录。

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

  • 匈牙利
      • Debrecen、匈牙利、4032
        • Debreceni Egyetem
  • 印度
    • Maharashtra
      • Mumbai、Maharashtra、印度、400012
        • Tata Memorial Hospital
      • Mumbai、Maharashtra、印度、400010
        • Prince Aly Khan Hospital
      • Pune、Maharashtra、印度、411004
        • Sahyadri Specialty Hospital
    • Tamil Nadu
      • Madurai、Tamil Nadu、印度、625107
        • Meenakshi Mission Hospital & Research Centre
    • West Bengal
      • Kolkata、West Bengal、印度、700156
        • TATA Medical Centre
  • 意大利
      • Milan、意大利、20122
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Roma、意大利、00161
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
      • Roma、意大利、00144
        • Ospedale Sant'Eugenio
    • Forli - Cesena
      • Meldola、Forli - Cesena、意大利、47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
    • Milano
      • Monza、Milano、意大利、20900
        • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
  • 比利时
      • Brussels、比利时、1200
        • Cliniques universitaires Saint-Luc
  • 法国
    • Bouches-du-Rhône
      • Marseille、Bouches-du-Rhône、法国、13273
        • Institut Paoli Calmettes
    • Rhone
      • Lyon、Rhone、法国、69373
        • Centre Léon Bérard
      • Pierre-Bénite、Rhone、法国、69495
        • Centre Hospitalier LYON SUD
  • 罗马尼亚
      • Bucharest、罗马尼亚、020125
        • Spitalul Clinic Colentina
      • Cluj-Napoca、罗马尼亚、400124
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Craiova、罗马尼亚、200143
        • Spitalul Clinic Municipal Filantropia Craiova
  • 美国
    • California
      • Downey、California、美国、90241
        • The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute
      • Los Angeles、California、美国、90024
        • UCLA Hematologic Malignancy Program
    • Florida
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic
    • Georgia
      • Augusta、Georgia、美国、30912
        • Board of Regents of the University System of Georgia
    • New York
      • New York、New York、美国、10065
        • Memorial Sloan Kettering Cancer Center - MAIN
    • Texas
      • Dallas、Texas、美国、75226
        • Baylor University Medical Center
      • Houston、Texas、美国、77030
        • MD Anderson Cancer Center
    • Utah
      • Salt Lake City、Utah、美国、84112
        • Huntsman Cancer Institute University of Utah
  • 英国
    • Greater London
      • London、Greater London、英国、SE5 9NU
        • King's College Hospital
      • London、Greater London、英国、W120HS
        • Hammersmith Hospital
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron
      • Madrid、西班牙、28034
        • Hospital Universitario Ramon y Cajal
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz
    • Barcelona
      • Badalona、Barcelona、西班牙、08916
        • ICO Badalona - Hospital Universitari Germans Trias i Pujol
  • 韩国
      • Gyeonggi-do、韩国、11759
        • Uijeongbu Eulji Medical Center, Eulji University
    • Gyeonggi-do
      • Seoul、Gyeonggi-do、韩国、6591
        • The Catholic University of Korea, Seoul St. Mary's Hospital

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 愿意并能够提供书面的、注明日期的知情同意书
  • ≥ 18 岁的男性或女性
  • 愿意并能够遵守预定的访问
  • 东部肿瘤合作组 (ECOG) 表现状态为 0、1 或 2
  • 被诊断患有 Ph+ CML-CP、Ph+ CML-AP、Ph+ CML-BP 且对 ≥ 3 种既往 TKI 耐药和/或不耐受的受试者，其中一种包括普纳替尼（Ponatinib）（C 部分）。

排除标准：

  • T315I 的存在（C 部分）
  • IMP 给药后 4 周内由研究者确定的任何大手术
  • 无法进行静脉穿刺和/或无法耐受静脉通路
  • 阳性排除试验：尿妊娠试验（如果适用）、HIV、乙型肝炎表面抗原或丙型肝炎病毒
  • 调查员判断的已知或疑似严重药物滥用史
  • 在 30 天内接受过任何其他研究药物或至少 5 个半衰期的洗脱，以较长者为准
  • 有资格接受可用的潜在治愈性治疗的受试者，包括造血干细胞移植
  • 过去 3 年或更早的另一种原发性恶性肿瘤（经过充分治疗的非黑色素瘤皮肤癌或原位宫颈癌除外

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：不适用
  • 介入模型：单组作业
  • 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：沃多巴替尼（K0706）胶囊
药品：Vodobatinib (K0706) capsules

Part A: Oral Vodobatinib (K0706) capsules in single ascending doses.

Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily.

Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily.

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
Examination of the Safety and Tolerability of Single Oral Doses of K0706
大体时间：Approximately 56 ± 2 days
Number of Participants with Adverse Events in Part A
Approximately 56 ± 2 days
To Determine the Maximum Tolerated Dose (MTD) as Determined by Frequency of Dose Limiting Toxicities
大体时间：Dose Limiting toxicities observed over a 4 week period
PART B
Dose Limiting toxicities observed over a 4 week period
Incidence and Severity of Treatment Emergent AEs (PART B)
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Number of Participants with treatment emergent Adverse Events in Part B
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in CP at Study Entry
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C: Proportion of subjects achieving Major Cytogenetic Response [ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)] as assessed by conventional Karyotyping of Bone marrow aspirate
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in AP at Study Entry
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C: Proportion of subjects achieving Major Hematologic Response [ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in BP at Study Entry
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C: Proportion of subjects achieving Major Hematologic Response [defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)

次要结果测量

结果测量
措施说明
大体时间
To Characterize the Pharmacokinetics (Cmax) of K0706 After Single Oral Doses in Healthy Male Subjects
大体时间：Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days
To Characterize the Pharmacokinetics of K0706 (Cmax) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
大体时间：Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
大体时间：All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
大体时间：All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - AUC[0-tau] (AUC Over the Dosing Interval of 0-24 Hours).
大体时间：All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Hematological Response as Assessed by Complete Blood Count of Peripheral Blood Sample
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Partial Cytogenetic Response (PCyR) as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
大体时间：All subjects will be followed up for 60 months from the first dose of K0706
Part C
All subjects will be followed up for 60 months from the first dose of K0706
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Time to Major Cytogenetic Response (MCyR): Time to MCyR is the Time From First Dose to First MCyR (0-35% Ph+ Metaphases); Computed Only for CML-CP Subjects Who Achieved MCyR
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Time to Major Molecular Response : Time to MMR is the Time From First Dose to First MMR (BCR-ABL1 Ratio of ≤ 0.1%) Computed Only for CML-CP Subjects Who Achieved MMR
大体时间：All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In All Subjects Progression Free Survival (PFS)
大体时间：All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
PART C
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
In All Subjects Overall Survival (OS)
大体时间：All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
PART C
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
Incidence and Severity of Treatment Emergent AEs (PART C)
大体时间：All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Number of Participants with treatment emergent Adverse Events in Part C
All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
大体时间：All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
大体时间：All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
PART C
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
To Characterize the Pharmacokinetics (AUC(0-inf)) of K0706 After Single Oral Doses in Healthy Male Subjects
大体时间：Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days
To Characterize the Pharmacokinetics of K0706 (AUC(0-inf)) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
大体时间：Approximately 28 ± 2 days
Part A
Approximately 28 ± 2 days

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

Sun Pharma Advanced Research Company Limited

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2016年6月27日

初级完成 (实际的)

2025年1月3日

研究完成 (实际的)

2025年1月3日

研究注册日期

首次提交

2015年12月10日

首先提交符合 QC 标准的

2015年12月10日

首次发布 (估计的)

2015年12月14日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年4月21日

最后验证

2026年4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

  • CLR_15_03 V 12 Amendment 12

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

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