A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
2026年8月28日 更新者：GlaxoSmithKline
A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Risvutatug Rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants With Metastatic Castration-resistant Prostate Cancer (EMBOLD Prostate-302)
This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better.
The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
684
段階
- フェーズ 3
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
- 名前：US GSK Clinical Trials Call Center
- 電話番号：877-379-3718
- メール：GSKClinicalSupportHD@gsk.com
研究連絡先のバックアップ
- 名前：EU GSK Clinical Trials Call Center
- 電話番号：+44 (0) 20 89904466
- メール：GSKClinicalSupportHD@gsk.com
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
- 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 ≥18 years of age
- Has histologically or cytologically confirmed adenocarcinoma of the prostate.
- Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization.
- Has a life expectancy of at least 4 months.
- Has adequate organ function
Exclusion Criteria:
- Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
- Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy,
- Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix] with no evidence of metastatic disease.
- Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization,
- Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
- Known active infectious diseases requiring systemic treatment or known human immunodeficiency virus (HIV)
- Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
- Has received systemic immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term administration [30 days or longer]).
- Has received any prior therapy with an ADC with a topoisomerase 1 inhibitor (TOPO1-inhibitor) payload
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 |
|---|---|
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実験的：Risvutatug rezetecan (Ris-Rez)
Participants will receive Risvutatug rezetecan (Ris-Rez).
|
Risvutatug rezetecan (Ris-Rez) will be administered.
|
|
アクティブコンパレータ：Standard of Care
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
|
アビラテロンを投与します。
エンザルタミドが投与されます。
Prednisone will be administered along with Abiraterone.
Prednisolone will be administered along with Abiraterone.
|
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 |
|---|---|---|
|
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
時間枠：Up to approximately 169 weeks
|
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
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Up to approximately 169 weeks
|
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Overall Survival (OS)
時間枠：Up to approximately 169 weeks
|
OS is defined as the time from randomization to date of death by any cause.
|
Up to approximately 169 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Pain Progression (TTPP)
時間枠：Up to approximately 169 weeks
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Up to approximately 169 weeks
|
|
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rPFS by Investigator assessment
時間枠：Up to approximately 169 weeks
|
rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first.
|
Up to approximately 169 weeks
|
|
Confirmed Objective Response Rate (cORR)
時間枠：Up to approximately 169 weeks
|
cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.
|
Up to approximately 169 weeks
|
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Duration of Response (DoR)
時間枠：Up to approximately 169 weeks
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DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first.
|
Up to approximately 169 weeks
|
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Time to Prostate-specific antigen (PSA) progression
時間枠：Up to approximately 169 weeks
|
Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.
|
Up to approximately 169 weeks
|
|
Prostate-specific antigen 50 (PSA50) response
時間枠：Up to approximately 169 weeks
|
PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later.
|
Up to approximately 169 weeks
|
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Time to first Symptomatic Skeletal-Related Event (SSRE)
時間枠：Up to approximately 169 weeks
|
Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events:
|
Up to approximately 169 weeks
|
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Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
時間枠：Up to approximately 169 weeks
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Up to approximately 169 weeks
|
|
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Number of participants with AEs leading to dose modifications or study intervention discontinuation
時間枠：Up to approximately 169 weeks
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Up to approximately 169 weeks
|
|
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Serum concentration of Ris-Rez (conjugated antibody and payload)
時間枠：Up to approximately 84 days
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Up to approximately 84 days
|
|
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Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
時間枠：Up to approximately 169 weeks
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Up to approximately 169 weeks
|
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Titers of ADA against Ris-Rez
時間枠：Up to approximately 169 weeks
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Up to approximately 169 weeks
|
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Participant-reported experience on study treatment
時間枠：Up to approximately 169 weeks
|
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
|
Up to approximately 169 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
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 (推定)
2026年9月22日
一次修了 (推定)
2029年12月19日
研究の完了 (推定)
2029年12月19日
試験登録日
最初に提出
2026年8月28日
QC基準を満たした最初の提出物
2026年8月28日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年8月28日
最終確認日
2026年8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
- 300145
- 2026-525558-13-00 (Ctis)
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
いいえ
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。