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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

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

113

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M5G 2M9
        • 募集
        • GSK Investigational Site
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Albiruni Ryan Ryan Abdul Abdul Razak
    • Quebec
      • Montreal、Quebec、カナダ、QC H3H 2R9
        • 募集
        • GSK Investigational Site
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Ramy Saleh
  • フランス
      • Bordeaux、フランス、33076
        • 募集
        • GSK Investigational Site
        • 主任研究者：
          • Maud Toulmonde
        • コンタクト：
        • コンタクト：
      • Lyon、フランス、69373
        • 募集
        • GSK Investigational Site
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Armelle Dufresne
      • Villejuif、フランス、94805
        • 募集
        • GSK Investigational Site
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Benjamin Verret
  • 日本
      • Hokkaido、日本、003-0804
        • 募集
        • GSK Investigational Site
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Hiroaki Hiraga

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Cohort 1A (Ris-Rez)
生物学的：リリ-レズ
Ris-Rez が投与されます
実験的：Cohort 1B [Ris-Rez + Granulocyte-Colony Stimulating Factor (G-CSF)]
生物学的：リリ-レズ
Ris-Rez が投与されます
生物学的：G-CSF
G-CSF will be administered
実験的：Cohort 2 (Ris-Rez)
生物学的：リリ-レズ
Ris-Rez が投与されます

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Cohort 1: Progression free survival rate at Week18 (PFS18)
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Cohort 1 & 2: Number of participants with Adverse events (AEs) and serious AEs (SAEs) by severity
時間枠：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
時間枠：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Number of participants with a change from baseline in vital signs
時間枠：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
時間枠：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)
時間枠：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)]
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Titers of ADA against Ris-Rez
時間枠：Up to approximately 179 weeks
Up to approximately 179 weeks
Cohort 1 & 2: Participant-reported experience on study treatment
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月22日

一次修了 (推定)

2027年11月18日

研究の完了 (推定)

2029年11月23日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月19日

最初の投稿 (実際)

2026年5月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月15日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 300640
  • 2025-523997-18 (その他の識別子：EU CT Number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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