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A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)

2026年7月13日 更新者：GlaxoSmithKline

Phase 1b/2 Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Previously Treated Unresectable Advanced or Metastatic Sarcomas

The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it, and how their bodies handle the drug (how its absorbed and broken down). This research is for adolescents and adults who have either: Osteosarcoma, which is a type of bone cancer, or Soft Tissue Sarcoma, which is a type of cancer that starts in soft body tissues (like muscle, fat, or nerves). In both cancer types the cancer must have already been treated, but has come back or spread, and cant be removed by surgery

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)

113

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。

学习联系方式

研究联系人备份

学习地点

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2M9
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Albiruni Ryan Ryan Abdul Abdul Razak
    • Quebec
      • Montreal、Quebec、加拿大、QC H3H 2R9
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Ramy Saleh
  • 日本
      • Hokkaido、日本、003-0804
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Hiroaki Hiraga
  • 法国
      • Bordeaux、法国、33076
        • 招聘中
        • GSK Investigational Site
        • 首席研究员：
          • Maud Toulmonde
        • 接触：
        • 接触：
      • Lyon、法国、69373
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Armelle Dufresne
      • Villejuif、法国、94805
        • 招聘中
        • GSK Investigational Site
        • 接触：
        • 接触：
        • 首席研究员：
          • Benjamin Verret

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

- Participants are eligible to be included in the study only if all of the following criteria apply

  • Participants must be ≥ 12 years of age.
  • Has histologically confirmed unresectable advanced or metastatic R/R OSA (Cohort 1) or unresectable advanced or metastatic STS (Cohort 2) that has progressed to at least one prior line of systemic therapy.
  • Has documented disease progression on the last line of systemic treatment as confirmed by radiological imaging
  • Has an ECOG performance status of 0 or 1, or Lansky PS/Karnofsky PS ≥ 70% for adolescent participants, with no deterioration in the 2 weeks prior to first dose/randomization.
  • Has adequate organ function.
  • All participants, or their legal guardians, must provide signed informed consent and agree to follow the study protocol before starting any study activities

Exclusion Criteria:

- Participants are excluded from the study if any of the following key exclusion criteria apply:

  • Has received any prior therapy with an Antibody-drug-conjugates (ADC) with a TOPO1-inhibitor payload.
  • Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
  • Has severe, uncontrolled or active cardiovascular disorders.
  • Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
  • Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases.
  • Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention.
  • Is pregnant or breastfeeding.

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：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：Cohort 1A (Ris-Rez)
生物：Oris-Rez（乙酰唑胺）
Ris-Rez 将被施用
实验性的：Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]
生物：Oris-Rez（乙酰唑胺）
Ris-Rez 将被施用
生物：G-CSF
G-CSF will be administered
实验性的：Cohort 2 (Ris-Rez)
生物：Oris-Rez（乙酰唑胺）
Ris-Rez 将被施用

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
Cohort 1: Progression free survival rate at Week18 (PFS18)
大体时间：At Week 18
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
At Week 18
Cohort 1 & 2: Confirmed Objective Response Rate (ORR)
大体时间：Up to approximately 98 weeks
Confirmed ORR is defined as the proportion of participants who have achieved a confirmed Complete Response (CR) or Partial Response PR as assessed by investigator, according to RECIST 1.1
Up to approximately 98 weeks

次要结果测量

结果测量
措施说明
大体时间
Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity
大体时间：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with AEs/SAEs leading to dose modifications or study intervention discontinuation or death
大体时间：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in vital signs
大体时间：Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in body weight
大体时间：Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in laboratory parameters (haematology and clinical chemistry)
大体时间：Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)]
大体时间：Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
大体时间：Baseline (Day-1) and up to approximately 179 weeks
Number of participants will be assessed
Baseline (Day-1) and up to approximately 179 weeks
Cohort 2: PFS rate at Week 18 (PFS18)
大体时间：At Week 18
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1
At Week 18
Cohort 1 & 2: Duration of response (DoR)
大体时间：Up to approximately 179 weeks
DoR is defined as the time from the date of the first documented objective response (CR/PR) that is subsequently confirmed, until the date of the first documented PD or death, whichever is earlier, as assessed by investigator according to RECIST 1.1
Up to approximately 179 weeks
Cohort 1 & 2: PFS rate at Week 30 (PFS30)
大体时间：At Week 30
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1
At Week 30
Cohort 1 & 2: PFS
大体时间：Up to approximately 179 weeks
PFS is defined as the time from the date of randomization until the date of documented disease progression or death due to any cause, whichever occurs first, as assessed by the investigator according to RECIST 1.1
Up to approximately 179 weeks
Cohort 1 & 2: Unconfirmed ORR
大体时间：Up to approximately 179 weeks
Unconfirmed ORR is defined as the proportion of participants who have achieved a response of CR or PR (without confirmation) as assessed by the investigator according to RECIST 1.1.
Up to approximately 179 weeks
Cohort 1 & 2: Observed pharmacokinetic (PK) concentration of Ris-Rez (conjugated antibody) and payload
大体时间：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Proportion of participants with positive and total Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
大体时间：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Titers of ADA against Ris-Rez
大体时间：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Participant-reported experience on study treatment
大体时间：Up to approximately 179 weeks
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Up to approximately 179 weeks

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

GlaxoSmithKline

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6月22日

初级完成 (估计的)

2027年11月18日

研究完成 (估计的)

2029年11月23日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月19日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年7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

  • 300640
  • 2025-523997-18 (其他标识符：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

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD 共享时间框架

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD 共享访问标准

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

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

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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