このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

転移性去勢抵抗性前立腺癌（mCRPC）の治療の安全性と有効性

2026年8月4日 更新者：Amgen

転移性去勢抵抗性前立腺癌 (mCRPC) の治療の安全性と有効性を評価するマスター プロトコル

これは、転移性去勢抵抗性前立腺がん (mCRPC) の参加者における治験療法の安全性と有効性を評価するために設計されたマスター プロトコルです。

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

これは、エンザルタミド、アビラテロン、または PD1 阻害剤 AMG 404、AMG 404 単剤療法と組み合わせたアカパタマブの安全性、忍容性、最大耐用量 (MTD) または推奨される第 2 相用量 (RP2D) および有効性を評価するために設計されたマスタープロトコルです。 、および転移性去勢抵抗性前立腺癌（mCRPC）の参加者におけるアカパタマブ単剤療法。

研究の種類

介入

入学 (実際)

55

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。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35294
        • University of Alabama at Birmingham
    • California
      • Orange、California、アメリカ、92868
        • University of California at Irvine Medical Center
      • San Francisco、California、アメリカ、94158
        • University of California San Francisco Mission Bay Campus
    • Illinois
      • Chicago、Illinois、アメリカ、60637
        • University of Chicago
    • Kentucky
      • Louisville、Kentucky、アメリカ、40207
        • Norton Cancer Institute
    • Texas
      • Dallas、Texas、アメリカ、75390
        • University of Texas Southwestern Medical Center
      • Houston、Texas、アメリカ、77030
        • University of Texas MD Anderson Cancer Center
  • イギリス
      • Sutton、イギリス、SM2 5PT
        • Royal Marsden Hospital
  • オーストラリア
    • New South Wales
      • Darlinghurst、New South Wales、オーストラリア、2010
        • St Vincents Hospital Sydney
  • スウェーデン
      • Lund、スウェーデン、221 85
        • Skanes universitetssjukhus
      • Stockholm、スウェーデン、171 76
        • Karolinska Universitetssjukhuset Solna
      • Uppsala、スウェーデン、75185
        • Akademiska sjukhuset
  • スペイン
    • Navarre
      • Pamplona、Navarre、スペイン、31008
        • Clinica Universidad de Navarra
  • デンマーク
      • København Ø、デンマーク、2100
        • Rigshospitalet

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

18年～99年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

すべての部品

包含基準:

  • 18歳以上（または国内の法定成人年齢）
  • -被験者は、研究固有の活動/手順の開始前にインフォームドコンセントを提供しています
  • -組織学的または細胞学的に前立腺の腺癌が確認されたmCRPCの被験者
  • -被験者は両側精巣摘除術を受けているか、ゴナドトロピン放出ホルモンアゴニストまたはアンタゴニスト（テストステロン≤50 ng / dL（または1.7 nmol / L））による継続的なアンドロゲン除去療法を受けている必要があります。

除外基準:

  • 中枢神経系（CNS）転移または軟髄膜疾患
  • 臨床的に関連する CNS 病理の病歴または存在
  • -確認された病歴または現在の自己免疫疾患または永続的な免疫抑制療法を必要とするその他の疾患
  • -心筋梗塞、制御不能な高血圧、不安定狭心症、投薬を必要とする心不整脈、および/または症候性うっ血性心不全（ニューヨーク心臓協会>クラスII） 12か月以内
  • mCRPCに対するタキサンによる前治療
  • 4週間以内の大手術および/または放射線

  • -重度の急性呼吸器症候群コロナウイルス2（SARS-CoV-2）感染の病歴または証拠 医療モニターと同意し、次の基準を満たしている場合を除きます。

    • -アカパタマブ（またはパート3のAMG 404）の初回投与から72時間以内のリアルタイムポリメラーゼ連鎖反応（RT-PCR）によるSARS-CoV-2 RNAの陰性検査
    • アカパタマブ（またはパート3のAMG 404）の初回投与前10日以内にCOVID-19疾患の急性症状がない（無症候性被験者の陽性検査の日からカウント）

以前/現在の臨床試験経験

  • -現在、別の治験機器または薬物研究で治療を受けているか、別の治験機器または薬物研究で治療を終了してから4週間未満。 この研究に参加している間の他の調査手順は、調査スキャンを除いて除外されます。

サブプロトコル A のみ:

包含基準

• mCRPC のために初めてエンザルタミドを投与する予定の被験者

除外基準

  • 強力な CYP2C8 阻害剤または強力な CYP3A4 誘導剤の使用
  • CYP3A4、CYP2C9、またはCYP2C19の基質である狭い治療指数の薬物の使用

サブプロトコル B のみ:

包含基準

  • mCRPCのために初めてアビラテロンを投与する予定の被験者 除外基準
  • -ベースラインの中等度および重度の肝障害（チャイルドピュークラスBおよびC）
  • コントロールされていない高血圧、低カリウム血症、または体液貯留の存在
  • -副腎皮質機能不全の病歴または存在
  • CYP2D6の感受性基質であり、治療指数が狭い併用薬の使用
  • 強力な CYP3A4 インデューサーの使用

サブプロトコル C のみ:

包含基準

  • -新規の抗アンドロゲン療法に抵抗性の被験者。 -被験者はタキサン療法の対象外であるか、拒否する必要があります。
  • -1つ以上のPCWG3基準として定義される進行性疾患の証拠：少なくとも1週間間隔で少なくとも2回連続して増加したPSAレベル> / = 1 ng / mL、PCGW3修正を伴うRECIST 1.1で定義された結節または内臓の進行、および/または骨スキャンにおける2つ以上の新しい病変の出現 除外基準
  • -間質性肺疾患または活動性の非感染性肺炎の病歴または証拠
  • -以前にPD-1またはPD-L1阻害剤を服用していた被験者で、投与初日の前にグレード3以上の免疫関連の有害事象が発生した

サブプロトコル D のみ:

包含基準

  • -被験者は、前立腺癌の新規ホルモン療法（NHT; 例：アビラテロン、エンザルタミド、アパルタミド、またはダロルタミド）を受けている可能性がありますが、転移性前立腺癌の場合は NHT が 1 つ以下です。
  • タキサン療法の不適格または拒否

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：順次割り当て
  • 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：アカパタマブとエンザルタミド：用量調査
研究の用量調査部分では、エンザルタミドと組み合わせた Acapatamab の MTD/推奨第 2 相用量 (RP2D) を推定します。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：エンザルタミド
エンザルタミドは経口投与されます。
他の名前：
  • アンドロゲン受容体阻害剤
実験的：アカパタマブとエンザルタミド：用量拡大
用量調査に続いて、選択された用量の安全性と忍容性を確認し、エンザルタミドと組み合わせたアカパタマブの有効性をさらに評価するために用量拡大が行われます。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：エンザルタミド
エンザルタミドは経口投与されます。
他の名前：
  • アンドロゲン受容体阻害剤
実験的：アカパタマブとアビラテロン：用量調査
研究の用量探索部分では、アビラテロンと組み合わせた Acapatamab の MTD/推奨第 2 相用量 (RP2D) を推定します。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：アビラテロン
アビラテロンは経口投与されます。
他の名前：
  • シトクロム P450 (CYP)17 阻害剤
実験的：アカパタマブとアビラテロン：用量拡大
用量調査に続いて、選択された用量の安全性と忍容性を確認し、アビラテロンと組み合わせたアカパタマブの有効性をさらに評価するために用量拡大が行われます。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：アビラテロン
アビラテロンは経口投与されます。
他の名前：
  • シトクロム P450 (CYP)17 阻害剤
実験的：アカパタマブと AMG 404: 用量調査
研究の用量調査部分では、AMG 404 と組み合わせたアカパタマブの MTD/RP2D を推定します。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：AMG 404
AMG 404 は、静脈内 (IV) 注入として投与されます。
他の名前：
  • PD-1阻害剤
実験的：アカパタマブと AMG 404: 用量拡大
用量調査に続いて、選択した用量の安全性と忍容性を確認し、AMG 404 と組み合わせたアカパタマブの有効性をさらに評価するために、用量拡大が行われます。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：AMG 404
AMG 404 は、静脈内 (IV) 注入として投与されます。
他の名前：
  • PD-1阻害剤
アクティブコンパレータ：AMG 404 単独療法
AMG 404 単剤療法は、mCRPC 集団における PD-1 阻害の予備的な抗腫瘍活性を評価するために実施されています。
薬：AMG 404
AMG 404 は、静脈内 (IV) 注入として投与されます。
他の名前：
  • PD-1阻害剤
実験的：アカパタマブとエンザルタミド：用量拡大アジアコホート
用量調査に続いて、用量調査で決定されたMTD / RP2Dの組み合わせでアジアコホートで用量拡大が行われ、アジアの被験者のエンザルタミドと組み合わせたアカパタマブの安全性、忍容性、およびPKが確認されます。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：エンザルタミド
エンザルタミドは経口投与されます。
他の名前：
  • アンドロゲン受容体阻害剤
実験的：アカパタマブとアビラテロン：用量拡大アジアコホート
用量調査に続いて、用量調査で決定されたMTD / RP2Dの組み合わせでアジアコホートで用量拡大が行われ、アジアの被験者に対するアビラテロンと組み合わせたアカパタマブの安全性、忍容性、およびPKが確認されます。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：アビラテロン
アビラテロンは経口投与されます。
他の名前：
  • シトクロム P450 (CYP)17 阻害剤
実験的：アカパタマブと AMG 404: 用量拡大アジア コホート
用量調査に続いて、用量調査で決定されたMTD / RP2Dの組み合わせでアジアコホートで用量拡大が行われ、アジアの被験者に対するAMG 404と組み合わせたアカパタマブの安全性、忍容性、およびPKが確認されます。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法
薬：AMG 404
AMG 404 は、静脈内 (IV) 注入として投与されます。
他の名前：
  • PD-1阻害剤
実験的：アカパタマブ単剤療法
アカパタマブ単剤療法は、mCRPC の被験者におけるアカパタマブの安全性、忍容性、薬物動態 (PK)、薬力学、および有効性を評価するために実施されています。
薬：アカパタマブ
アカパタマブは静脈内（IV）注入として投与されます。
他の名前：
  • PSMA標的療法

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
Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
時間枠：Cycle 1: Day 1 to Day 28 (28-day cycle)

DLTs were defined as any adverse event (AE) (per Common Terminology Criteria for Adverse Events (CTCAE) v5: Grade 5=Death, Grade 4=Life-threatening, Grade 3=Moderate) occurring within 28 days of the first AMG 160 dose, possibly related to the treatment, including:

  • Grade 5 toxicity
  • Grade 4 thrombocytopenia
  • Grade 3 thrombocytopenia with significant hemorrhage
  • Grade 4 neutropenia > 5 days
  • Febrile neutropenia
  • Grade 3 anemia requiring transfusion
  • Grade ≥3 non-hematologic toxicity (with exceptions per protocol)
  • Aspartate transaminase/alanine transaminase >3x upper limit of normal (ULN) with serum total bilirubin >2x ULN without cholestasis or another clear cause
  • Grade ≥3 non-hematological toxicity delaying treatment > 2 weeks or resulting in <75% dose administration.

The complete list of DLTs are described in the protocol
Cycle 1: Day 1 to Day 28 (28-day cycle)
Subprotocols A, B and C (Parts 1 and 2): Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs
時間枠：From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months

A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started on or after first dose of investigational product (AMG 160 or AMG 404 for Part 1 and 2; AMG 404 for Part 3).

A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab, or AMG 404 (subprotocol C, parts 1 and 2 only).

Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs.
From first dose of acapatamab/AMG 404 to the first of 30 days after last dose of acapatamab/AMG404, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 4.665 (0.33, 25.17) months
Subprotocol D: Number of Participants Who Experienced TEAEs and Treatment-related AEs
時間枠：From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months

A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab.

A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab.

Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs.
From first dose of acapatamab to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy, whichever is earlier; median (min, max) duration was 4.665 (0.33, 25.17) months
Subprotocol C, Part 3: Objective Response Rate (ORR)
時間枠：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
Objective Response is defined as a complete response (CR) or partial response (PR) per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or end of trial median (min, max) duration was 6.14 (0.14, 105.14) weeks
Subprotocol C, Part 3: Percentage of Participants Who Experienced a Circulating Tumor Cell 0 (CTC0) Response
時間枠：Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement). The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1.
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
Subprotocol C, Part 3: Percentage of Participants Who Experienced a CTC Conversion Response
時間枠：Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement. The baseline was defined as the last non-missing value on or prior to the pre-dose assessments of AMG 404 on Cycle 1 Day 1.
Cycle 1 Day 1 to 14 days post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)
Subprotocol C, Part 3: Percentage of Participants Who Experienced a Prostate Specific Antigen (PSA) Response
時間枠：Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)

A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:

  • PSA 30 response: ≥ 30% reduction from the baseline PSA.
  • PSA 50 response: ≥ 50% reduction from the baseline PSA.
  • PSA 70 response: ≥ 70% reduction from the baseline PSA.
  • PSA 90 response: ≥ 90% reduction from the baseline PSA.

The baseline was defined as the last non-missing value on or prior to the pre-dose of AMG 404 assessments on Cycle 1 Day 1.
Cycle 1 Day 1 to 5 months post-last dose of AMG 404 (each cycle was 28 days, maximum duration of AMG 404 treatment was 105.1 weeks)

二次結果の測定

結果測定
メジャーの説明
時間枠
Subprotocols A. B, C (Parts 1 and 2) and D: ORR
時間枠：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Objective Response is defined as a CR or PR per RECIST 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a confirmed CR or PR, or did not have any follow-up tumor assessments were regarded as non-responders.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC0 Response
時間枠：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
CTC0 response was defined as CTC0 (reduction of CTCs > 0 to 0 at any post-baseline measurement). The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1 > 0.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a CTC Conversion Response
時間枠：From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
CTC conversion response was defined as ≥ 5 CTCs/7.5 mL blood at baseline that converted to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement. The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1.
From Cycle 1 Day 1 until progression, start of new anticancer therapy, or until end of trial (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1 and 2) and D: Percentage of Participants Who Experienced a PSA Response
時間枠：Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)

A PSA response was defined as the below and must have been confirmed by a second consecutive value 3 weeks later:

  • PSA 30 response: ≥ 30% reduction from the baseline PSA.
  • PSA 50 response: ≥ 50% reduction from the baseline PSA.
  • PSA 70 response: ≥ 70% reduction from the baseline PSA.
  • PSA 90 response: ≥ 90% reduction from the baseline PSA.

The baseline was defined as the last non-missing value on or prior to the pre-dose of acapatamab assessments on Cycle 1 Day 1.
Cycle 1 Day 1 to 5 months post-last dose of acapatamab/AMG 404 (each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC0 Response
時間枠：From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of CTC0 response was defined as the time from the date of initial CTC0 response to the earlier of CTC0 progression or death. Participants who had not ended their response at the time of analysis had duration of CTC0 response censored on the date of their last CTC0 or CTC conversion assessment.
From date of initial CTC0 response to the earlier of CTC0 progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of CTC Conversion Response
時間枠：From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of CTC conversion response was defined as the time from the date of an initial CTC conversion response to the earlier of CTC conversion progression or death. Participants who had not ended their response at the time of analysis had duration of CTC response censored on the date of their last CTC0 or CTC conversion assessment.
From the date of an initial CTC conversion response to the earlier of CTC conversion progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of PSA Response
時間枠：From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of PSA response was defined as the time of an initial PSA response (PSA 50) to the earlier of PSA progression or death. Participants who had not ended their response at the time of analysis had duration of PSA response censored on the date of their last PSA measurement.
From date of an initial PSA response (PSA 50) to the earlier of PSA progression or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Duration of Response Per RECIST 1.1
時間枠：From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Duration of response per RECIST 1.1 was defined as the time from the date of an initial objective response (CR/PR) per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death. CR/PR must have been confirmed at least 4 weeks later. Participants who had not ended their response at the time of analysis had duration of response censored at their last evaluable tumor assessment by computed tomography (CT)/magnetic resonance imaging (MRI) scan.
From date of an initial objective response per RECIST 1.1 to the earlier of soft-tissue progression per RECIST 1.1 or death (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Overall Survival (OS)
時間枠：From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
OS was defined as the time from the date of trial Day 1 until death due to any cause. OS time (months) = (date of death - trial Day 1 + 1) x 12/365.25. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was alive. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Kalbfleisch and Prentice.
From the date of study Day 1 until death due to any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Radiographic Progression Free Survival (rPFS)
時間枠：From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
rPFS was defined as the time from trial Day 1 to radiographic progression. If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without disease progression (PD) or death recorded, rPFS was censored on the date of the first dose of the investigational product (IP). rPFS was censored at the last evaluable radiographic tumor assessment date for participants who had no PD, death or new anti-cancer therapy reported, started a new anti-cancer therapy prior to PD or death, if death recorded without new anti-cancer therapy and without PD, if death or PD immediately after more than one consecutively missed tumor assessment occurred. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the earlier of a radiographic progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: PSA PFS
時間枠：From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
PSA PFS was defined as the interval from trial Day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS was censored on the date of the last PSA measurement. If a participant had no baseline or post-baseline PSA measurement and a vital status of alive or known, PSA PFS was censored at trial Day 1. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the earlier of a PSA progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Clinical PFS
時間枠：From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Clinical PFS was defined as the time from the first dose to clinical disease progression or death from any cause. If a participant had no evaluable post-baseline or on-trial disease assessment or was on trial without PD or death recorded, clinical PFS was censored on the date of the first dose of the IP. Otherwise, clinical PFS was censored on the date of last assessment. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From first dose of acapatamab or AMG 404 (subprotocol C only) to clinical disease progression or death from any cause (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Radiographic Progression
時間枠：From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)

Time to radiographic progression was defined as the interval from Day 1 to radiographic progression in the absence of subsequent anticancer therapy. If a participant had no evaluable post-baseline and on-trial disease assessment and was on trial without PD or death recorded, time to radiographic progression was censored on the date of the first dose of the IP. Time to radiographic progression was censored on the date of last evaluable radiographic tumor assessment for participants who:

  • had no PD but death recorded without new anti-cancer therapy;
  • had no PD, death, or new anti-cancer therapy;
  • had PD or death immediately after more than one consecutively missed tumor assessment;
  • started new anti-cancer therapy prior to PD or death, or prior to any other disease assessment if there is no PD or death.

The median was estimated using the Kaplan-Meier method and the 95% CI was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to radiographic progression in the absence of subsequent anticancer therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to PSA Progression
時間枠：From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Time to PSA progression was defined as the interval from trial Day 1 to PSA progression. If a participant had no evaluable post-baseline or on-trial PSA assessment, time to PSA progression was censored on the date of the first dose of the IP. Otherwise, time to PSA progression was censored on the date of the last PSA assessment. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to PSA progression (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Subsequent Therapy
時間枠：From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Time to subsequent therapy was defined as the interval from trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy; otherwise, time to subsequent therapy was censored at the last known date of any of the trial assessments prior to initiating the subsequent cancer therapy/subsequent therapy. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the time a participant starts/receives the subsequent cancer therapy/subsequent therapy (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Percentage of Participants Who Experienced a Gallium Prostate-specific Membrane Antigen-11 (PSMA-11) Response
時間枠：Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
A Gallium PSMA-11 response was defined as a ≥ 50% reduction from baseline in the maximum standardized update value (SUV) using 68Gallium (68Ga)-PSMA-11 positron emission tomography (PET)/CT. PSMA-11 response percentages were based on the number of participants with a baseline PSMA assessment (defined as the last non-missing value on or prior to the pre-dose of acapatamab/AMG 404 assessments) on Cycle 1 Day 1. The 95% confidence interval was calculated based on the Clopper-Pearson method.
Cycle 1 Day 1 to 14 days post-last dose of acapatamab or AMG 404 (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Time to Symptomatic Skeletal Events
時間枠：From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Time to symptomatic skeletal events was defined as time from trial Day 1 to the first symptomatic skeletal event, otherwise time to symptomatic skeletal event was censored at the last dose of acapatamab/AMG 404 or end of safety follow-up date, whichever was later. Symptomatic skeletal events included fracture, spinal cord compression and radiation or surgery to bone. The median was estimated using the Kaplan-Meier method and the 95% confidence interval was estimated using the method by Brookmeyer and Crowley.
From trial Day 1 to the first symptomatic skeletal event (maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.14 weeks)
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Total Alkaline Phosphatase Levels
時間枠：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Alkaline phosphatase levels were collected locally and centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Bone Specific Alkaline Phosphatase Levels
時間枠：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Bone specific alkaline phosphatase levels were collected locally and centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Lactate Dehydrogenase Levels
時間枠：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Lactate dehydrogenase levels were collected locally and centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Hemoglobin Levels
時間枠：Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Hemoglobin levels were collected locally.
Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Neutrophil-to-lymphocyte Ratio
時間枠：Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Data for the neutrophil-to-lymphocyte ratio were collected locally. Neutrophil-to-lymphocyte ratio was calculated by dividing the number of absolute neutrophils by the number of lymphocytes.
Baseline, safety follow-up visit (up to 30 days post-last dose of acapatamab/AMG 404), safety follow-up 2 (subprotocol C only, up to 5 months post-dose). Each cycle = 28 days, max acapatamab duration = 98.43 weeks, max AMG 404 duration = 105.1 weeks.
Subprotocols A, B, C (Parts 1, 2 and 3) and D: Urine N-telopeptide Levels
時間枠：Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Urine N-telopeptide levels were collected centrally.
Baseline and end of treatment visit (up to 14 days post-last dose of acapatamab/AMG 404. Each cycle was 28 days, maximum duration of acapatamab treatment was 98.43 weeks/AMG 404 treatment was 105.1 weeks).
Subprotocol A, B and C (Parts 1 and 2) and D: Maximum Serum Concentration (Cmax) of Acapatamab
時間枠：Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol A, B and C (Parts 1 and 2) and D: Area Under the Curve Over the Dosing Interval (AUCtau)
時間枠：Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol A, B and C (Parts 1 and 2) and D: Time to Reach Cmax (Tmax) of Acapatamab
時間枠：Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 1: Days 1 to 7 and Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol A, B and C (Parts 1 and 2) and D: Terminal Half-life (t1/2z) of Acapatamab
時間枠：Cycle 2: Days 1 to 14 (each cycle was 28 days)
Serum concentrations of acapatamab were determined using a validated assay.
Cycle 2: Days 1 to 14 (each cycle was 28 days)
Subprotocol C, Part 3: Number of Participants Who Experienced TEAEs and Treatment-related AEs
時間枠：From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) weeks

A TEAE was defined as any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment that started after the first dose of acapatamab.

A treatment-related TEAE was defined as a TEAE that had a reasonable possibility of being caused by acapatamab.

Clinically significant changes from baseline in vital signs and clinical laboratory tests were also recorded as TEAEs.
From first dose of AMG 404 to the first of 30 days after last dose of acapatamab, end of trial date or the initiation of a new anticancer therapy; median (min, max) duration was 6.14 (0.14, 105.14) 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

Amgen

捜査官

  • スタディディレクター：MD、Amgen

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

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)

2021年1月15日

一次修了 (実際)

2023年10月23日

研究の完了 (実際)

2023年10月23日

試験登録日

最初に提出

2020年11月13日

QC基準を満たした最初の提出物

2020年11月13日

最初の投稿 (実際)

2020年11月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月26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4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

  • 20190505
  • 2020-001305-23 (EudraCT番号)

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

承認されたデータ共有リクエストで特定の研究課題に対処するために必要な変数の匿名化された個々の患者データ。

IPD 共有時間枠

この研究に関連するデータ共有リクエストは、研究が終了してから 18 か月後に開始されると見なされ、1) 米国とヨーロッパの両方で製品と適応症に販売承認が付与されているか、2) 製品および/または適応症の臨床開発が中止されています。データは規制当局に提出されません。 この調査のデータ共有リクエストを送信する資格の終了日はありません。

IPD 共有アクセス基準

有資格の研究者は、研究目的、範囲内の Amgen 製品および Amgen 研究/研究、関心のあるエンドポイント/結果、統計分析計画、データ要件、出版計画、および研究者の資格を含む要求を提出することができます。 一般に、アムジェン社は、製品ラベルですでに対処されている安全性と有効性の問題を再評価する目的で、個々の患者データに対する外部からの要求を許可しません. 要求は、内部アドバイザーの委員会によって審査されます。 承認されない場合、データ共有の独立審査委員会が仲裁を行い、最終決定を下します。 承認されると、研究課題に対処するために必要な情報が、データ共有契約の条件に基づいて提供されます。 これには、匿名化された個々の患者データおよび/または分析仕様で提供される分析コードのフラグメントを含む利用可能なサポート ドキュメントが含まれる場合があります。 詳細は下記ＵＲＬにて。

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。

購読する