転移性去勢抵抗性前立腺がんにおけるBNT324とドセタキセルの第III相臨床試験
転移性去勢抵抗性前立腺がんにおけるBNT324対ドセタキセル＋プレドニゾン／プレドニゾロンの第III相無作為化オープンラベル試験
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.
The main goals of this study are:
- To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival [rPFS]).
- To find out if BNT324 helps participants live longer overall (overall survival [OS]).
調査の概要
詳細な説明
The study consists of a screening period (up to 28 days), a treatment period with 21-day cycles, and an after-treatment period that includes a 30-day safety follow-up period and a long-term survival follow-up period.
Treatment continues until the cancer clearly gets worse (in scans, based on blinded independent central review [BICR] assessment or investigator's decision), side effects become unacceptable, the participant chooses to stop, or the study ends.
Participants are put into one of two groups in a 1:1 ratio, which means they will have an equal chance to be in either treatment group, i.e., BNT324 group, or docetaxel plus prednisone/prednisolone group (current SoC). An independent committee will help ensure participant safety, by regularly reviewing safety and early results.
For each participant, the treatment and follow-up periods are projected to be up to ~58 months.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：BioNTech clinical trials patient information
- 電話番号：+49 6131 9084
- メール：patients@biontech.de
研究場所
-
-
California
-
Santa Barbara、California、アメリカ、93105
- 募集
- Sansum Clinic
-
-
Colorado
-
Aurora、Colorado、アメリカ、80012
- 募集
- Rocky Mountain Cancer Centers
-
-
Florida
-
Fort Myers、Florida、アメリカ、33901
- 募集
- Florida Cancer Specialists- Fort Myers
-
St. Petersburg、Florida、アメリカ、33701
- 募集
- Florida Cancer Specialists- St. Petersburg
-
West Palm Beach、Florida、アメリカ、33401
- 募集
- Florida Cancer Specialists- West Palm Beach
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30318
- 募集
- Piedmont Cancer Institute
-
-
Illinois
-
Niles、Illinois、アメリカ、60714
- 募集
- Illinois Cancer Specialists
-
Peoria、Illinois、アメリカ、61615
- 募集
- Illinois CancerCare PC
-
-
Maryland
-
Rockville、Maryland、アメリカ、20850
- 募集
- Maryland Oncology Hematology
-
-
New York
-
Albany、New York、アメリカ、12206
- 募集
- NYOH Albany Cancer Center
-
White Plains、New York、アメリカ、10601
- 募集
- White Plains Hospital
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45242
- 募集
- Oncology/Hematology Care, Inc.
-
-
South Carolina
-
Myrtle Beach、South Carolina、アメリカ、29572
- 募集
- START Carolinas
-
-
Tennessee
-
Nashville、Tennessee、アメリカ、37203
- 募集
- Tennessee Oncology
-
Nashville、Tennessee、アメリカ、37203
- 募集
- SCRI Oncology Partners
-
-
Texas
-
Austin、Texas、アメリカ、78731
- 募集
- Texas Oncology South Austin
-
Houston、Texas、アメリカ、77024
- 募集
- Texas Oncology Gulf Coast
-
Tyler、Texas、アメリカ、75702
- 募集
- Texas Oncology, P.A. - Tyler
-
Wichita Falls、Texas、アメリカ、76310
- 募集
- Texas Oncology - West Texas
-
-
Virginia
-
Fairfax、Virginia、アメリカ、22031
- 募集
- Virginia Cancer Specialists PC
-
Norfolk、Virginia、アメリカ、23502
- 募集
- Virginia Oncology Associates
-
-
-
-
-
Cambridge、イギリス、CB2 0QQ
- 募集
- Addenbrooke's Hospital
-
Cardiff、イギリス、CF14 2TL
- 募集
- Velindre Cancer Centre
-
Leeds、イギリス、LS9 7TF
- 募集
- St James's University Hospital
-
London、イギリス、SW3 6JJ
- 募集
- Royal Marsden Hospital
-
Newcastle upon Tyne、イギリス、NE7 7DN
- 募集
- Freeman Hospital
-
Southampton、イギリス、SO16 6YD
- 募集
- Southampton General Hospital
-
Sutton、イギリス、SM2 5PT
- 募集
- Royal Marsden Hospital
-
-
-
-
-
Southport、オーストラリア、4215
- 募集
- Tasman Onco Research Pty Ltd
-
-
-
-
-
Dresden、ドイツ、1307
- 募集
- Universitätsklinikum Carl Gustav Carus
-
Hamburg、ドイツ、22763
- 募集
- Asklepios Klinik Altona
-
-
-
-
-
Brussels、ベルギー、1200
- 募集
- Cliniques Universitaires Saint-Luc
-
-
-
-
-
Krakow、ポーランド、30-727
- 募集
- Pratia MCM Krakow
-
Warsaw、ポーランド、02-781
- 募集
- National Research Institute of Oncology - National Research Institute (NIO-PIB)
-
-
-
-
-
Beijing、中国、100142
- 募集
- Beijing Cancer Hospital
-
Beijing、中国、100034
- 募集
- Peking University First Hospital
-
Changsha、中国、410005
- 募集
- The First Affiliated Hospital of Hunan Normal University
-
Chengdu、中国、610041
- 募集
- West China Hospital, Sichuan University
-
Chongqing、中国、400072
- 募集
- The Second Affiliated Hospital of Chongqing Medical University
-
Fuzhou、中国、350001
- 募集
- Fujian Medical University Union Hospital
-
Hangzhou、中国、310022
- 募集
- Zhejiang Cancer Hospital
-
Hangzhou、中国、310016
- 募集
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
-
Hefei、中国、230601
- 募集
- Second Hospital of Anhui Medical University
-
Nanchang、中国、330006
- 募集
- The First Affiliated Hospital of Nanchang University
-
Nanjing、中国、210008
- 募集
- Nanjing Drum Tower Hospital
-
Shanghai、中国、200032
- 募集
- Shanghai Cancer Center
-
Shanghai、中国、200072
- 募集
- No. 10 People's Hospital of Shanghai
-
Wenzhou、中国、325000
- 募集
- The First Affiliated Hospital of Wenzhou Medical University
-
Wuhan、中国、430079
- 募集
- Hubei Cancer Hospital
-
Wuhan、中国、420104
- 募集
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Wuhu、中国、241001
- 募集
- Yijishan Hospital of Wannan Medical College
-
Yantai、中国、264000
- 募集
- Yantai Yuhuangding Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Key Inclusion Criteria:
-
Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
-
Must have documented progressive prostate cancer based on at least one of the following criteria:
- Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.
- Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
- Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
-
Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.
-
Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.
-
Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.
-
Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.
Key Exclusion Criteria:
- Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
- Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
研究計画
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：BNT324
|
Intravenous infusion
他の名前：
|
|
アクティブコンパレータ：ドセタキセル＋プレドニゾロン／プレドニゾロン
|
Intravenous infusion Oral |
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 |
|---|---|---|
|
rPFS assessed by BICR
時間枠：From randomization to end of study, i.e., up to 58 months
|
By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
|
|
OS
時間枠：From randomization to end of study, i.e., up to 58 months
|
By arm. OS is defined as time from randomization to death from any cause. |
From randomization to end of study, i.e., up to 58 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to first subsequent therapy (TFTS)
時間枠：From randomization to end of study, i.e., up to 58 months
|
By arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
|
|
Objective response rate (ORR)
時間枠：From randomization to end of study, i.e., up to 58 months
|
By arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response. |
From randomization to end of study, i.e., up to 58 months
|
|
Duration of response (DOR)
時間枠：From randomization to end of study, i.e., up to 58 months
|
By arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
|
|
Time to pain progression (TTPP)
時間枠：From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
|
By arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 "worst pain in 24 hours" and opiate analgesic use (Analgesic Quantification Algorithm score). |
From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
|
|
rPFS as assessed by investigator
時間枠：From randomization to end of study, i.e., up to 58 months
|
By arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
|
|
Time to first symptomatic skeletal-related event (SSRE)
時間枠：From randomization to end of study, i.e., up to 58 months
|
By arm. Time to first SSRE is defined as time from randomization to first occurrence of any of the following SSREs:
|
From randomization to end of study, i.e., up to 58 months
|
|
Time to prostate-specific antigen (PSA) progression (by central lab testing results)
時間枠：From baseline to end of treatment visit, i.e., up to 58 months
|
By arm. Time to PSA progression is defined as time from randomization to PSA progression per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
|
|
PSA response (by central lab testing results)
時間枠：From baseline to end of treatment visit, i.e., up to 58 months
|
By arm. PSA response is defined as having a post-baseline PSA reduction ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
|
|
Number and percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs
時間枠：From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
TEAEs by relationship and by arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
|
Number and percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs
時間枠：From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
By arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：BioNTech Responsible Person、BioNTech SE
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BNT324-03
- 2025-524445-27-00 (Ctis)
- 2025 (米国 NIH グラント/契約)
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?
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
米国FDA規制機器製品の研究
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。