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一项针对标准疗法失败的晚期或转移性癌症患者的ITC-6146RO研究

2026年11月5日 更新者：IntoCell, Inc

一项针对ITC-6146RO在标准治疗失败的晚期或转移性癌症患者中的安全性、耐受性、药代动力学及初步抗肿瘤疗效评估的1a/b期、开放标签、多中心、首次人体、剂量递增/扩展、含多个队列的研究

The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD).

In Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

102

阶段

  • 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。

学习联系方式

  • 姓名：EUNJU JEON, PhD
  • 电话号码：042-716-0151 010-7557-3589
  • 邮箱：ejjeon@intocell.com

研究联系人备份

  • 姓名：SOOJIN OH, MS
  • 电话号码：042-716-0339 010-7664-7484
  • 邮箱：sjoh@intocell.com

学习地点

  • 韩国
    • Seoul
      • Seoul、Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
        • 接触：
      • Seoul、Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
        • 接触：
      • Seoul、Seoul、韩国、03722
        • 招聘中
        • Severance Hospital
        • 接触：

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
  2. Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.
  3. Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
  4. Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)
  5. Patients who have received standard therapies and have no remaining clinically available approved treatment options.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. Estimated life expectancy of ≥ 3 months

Exclusion Criteria:

  1. Inability to comply with study and follow-up procedures
  2. Patients with a prior history of anticancer therapy before the first dose
  3. History of another active malignancy within the past 3 years
  4. Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
  5. Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO
  6. Has prior treatment with duocarmycin-containing agents
  7. Pregnancy, lactation, or breastfeeding
  8. Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.
  9. Tuberculosis with active disease
  10. Active infection necessitating systemic therapy
  11. Prior allogenic bone marrow transplantation or solid organ transplantation
  12. History of autoimmune disease, treatment with systemic immunosuppressive medications
  13. Patients with clinically significant pulmonary disease

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：顺序分配
  • 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：Phase 1a/b

The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part.
药品：ITC-6146RO

ITC-6146RO will be administered as an intravenous (IV) infusion at protocol-specified dose levels and schedules in Phase 1a (dose escalation) and Phase 1b (dose expansion).

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
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
大体时间：Through study completion (Up to 2 years)

Grade 3 and 4 AEs, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-limiting toxicities (DLTs) and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs , n, (%)
Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Incidence of AEs
大体时间：Through study completion (Up to 2 years)

Grade 3 and 4 AEs, TEAEs, SAEs and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs, n, %
Through study completion (Up to 2 years)

次要结果测量

结果测量
措施说明
大体时间
Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

MTD/OBD will be reported as the final selected dose level for further investigation from Phase 1a dose escalation. MTD is determined by DLTs observed during the prespecified DLT observation period, and OBD is determined by meeting prespecified biological activity criteria (as defined in the protocol).
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Single-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma AUClast following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Single-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma AUCinf following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma Cmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma terminal elimination half-life (t1/2) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration (Tmax) After Single-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma Tmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma apparent clearance (CL) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma apparent volume of distribution (Vz) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma AUClast following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration at Steady State (Cmax,ss) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma Cmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Trough Plasma Concentration at Steady State (Ctrough,ss) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma Ctrough,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Average Plasma Concentration Over the Dosing Interval at Steady State (Cav,τ) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma Cav,τ (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life at Steady State (t1/2,ss) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma terminal elimination half-life at steady state (t1/2,ss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma Tmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance at Steady State (CLss) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma apparent clearance at steady state (CLss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution at Steady State (Vss) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Plasma apparent volume of distribution at steady state (Vss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Accumulation Ratio After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Accumulation ratio (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Peak-to-Trough Fluctuation (PTF) After Multiple-Dose Administration of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Peak-to-trough fluctuation (PTF) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.
Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Incidence of Anti-Drug Antibodies (ADAs) to ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Percentage of participants with detectable ADAs to ITC-6146RO (ADA-positive) based on a validated immunoassay.
Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Population Pharmacokinetic (PopPK) Parameters of ITC-6146RO
大体时间：Through study completion (Up to 2 years)

PopPK parameters (e.g.,clearance and volume of distribution) will be estimated using PopPK modeling based on measured ITC-6146RO concentrations.
Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Incidence of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to ITC-6146RO
大体时间：Through study completion (Up to 2 years)

Percentage of participants with detectable ADAs, including NAbs, to ITC-6146RO, as determined by validated immunoassay and neutralization assays (as applicable).
Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Objective Response Rate (ORR) by Investigator per RECIST v1.1
大体时间：Through study completion (Up to 2 years)

ORR will be assessed by the investigator per RECIST v1.1
Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Duration of Response (DoR) by Investigator per RECIST v1.1
大体时间：Through study completion (Up to 2 years)

DoR will be assessed by the investigator per RECIST v1.1
Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Time to Response (TTR) by Investigator per RECIST v1.1
大体时间：Through study completion (Up to 2 years)

TTR will be assessed by the investigator per RECIST v1.1
Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Progression-Free Survival (PFS) by Investigator per RECIST v1.1
大体时间：Through study completion (Up to 2 years)

PFS will be assessed by the investigator per RECIST v1.1
Through study completion (Up to 2 years)

其他结果措施

结果测量
措施说明
大体时间
Phase 1b (Dose Expansion) Association Between ITC-6146RO Pharmacokinetic Parameters and Efficacy and Safety Endpoints
大体时间：Through study completion (Up to 2 years)

Correlation between ITC-6146RO pharmacokinetic (PK) parameters and selected efficacy, safety, and exploratory endpoints. Efficacy endpoints may include objective response rate (ORR) and progression-free survival (PFS). Associations will be evaluated using appropriate exposure-response analyses.
Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Overall Survival (OS)
大体时间：Through study completion (Up to 2 years)

OS is defined as the time from randomization until death from any cause.
Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Association Between B7-H3 Expression in Tumor Tissue and Anti-Tumor Efficacy
大体时间：Through study completion (Up to 2 years)

Correlation between B7-H3 expression in tumor tissue assessed by immunohistochemistry (IHC) and anti-tumor efficacy endpoints, including objective response rate (ORR) and progression-free survival (PFS). ORR is defined as the proportion of participants with confirmed complete or partial response, and PFS as time to disease progression or death per protocol-defined criteria. Associations will be evaluated using appropriate statistical methods. In participants with metastatic castration-resistant prostate cancer (mCRPC), PSA response rate (≥50% decline from baseline) and time to PSA progression will also be assessed.
Through study completion (Up to 2 years)

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

IntoCell, Inc

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)

2026年3月24日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年2月4日

首先提交符合 QC 标准的

2026年2月18日

首次发布 (实际的)

2026年2月20日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ITC06P1-P01

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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