成人の初回治療転移性膵管腺癌患者における、フルオロウラシル、ホリニック酸、オキサリプラチン（FOLFOX）と併用した静脈内（IV）テリソツズマブ・アジズテカンの標準治療との比較試験
テリソツズマブ・アジズテカンとFOLFOX併用療法の標準治療との比較による、前線治療未治療転移性膵管腺癌患者を対象とした第2/3相オープンラベル無作為化試験 - AndroMETa-PDAC-288
Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan when given in combination with fluorouracil, folinic acid, and oxaliplatin (FOLFOX) to treat adult participants with pancreatic ductal cancer.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study will be divided into two phases, with the first phase (Phase 2) treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX. Participants will then be randomized into 3 groups called treatment arms. Two groups will receive telisotuzumab adizutecan with FOLFOX with different optimized doses. One group will receive standard of care (SOC) - fluorouracil, leucovorin, oxaliplatin, and irinotecan. In the second phase (Phase 3), participants will be randomized into 2 arms to receive either the optimal dose of telisotuzumab adizutecan (from the previous phase) with FOLFOLX, or SOC. Approximately 900 participants with PDAC will be enrolled in this study in approximately 200 sites worldwide.
Phase 2 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + FOLFOX. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with FOLFOX or SOC. At the start of Phase 3, participants will receive the optimal dose of IV telisotuzumab adizutecan with FOLFOX or SOC. The study will run for a duration of approximately 6 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
研究連絡先
- 名前：ABBVIE CALL CENTER
- 電話番号：844-663-3742
- メール：abbvieclinicaltrials@abbvie.com
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06511
- 募集
- Smilow Cancer Center At Yale-New Haven /ID# 279780
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Illinois
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Chicago、Illinois、アメリカ、60637
- 募集
- University of Chicago Medical Center /ID# 279460
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Zion、Illinois、アメリカ、60099
- 募集
- City Of Hope - Chicago /ID# 279814
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Michigan
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Grand Rapids、Michigan、アメリカ、49503
- 募集
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853
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Missouri
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St Louis、Missouri、アメリカ、63110
- 募集
- Washington University /ID# 279890
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Ohio
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Cleveland、Ohio、アメリカ、44106
- 募集
- UH Seidman Cancer Center /ID# 279602
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 280038
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Texas
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Tyler、Texas、アメリカ、75702
- 募集
- Texas Oncology - Northeast Texas /ID# 280417
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Virginia
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Fairfax、Virginia、アメリカ、22031
- 募集
- Virginia Cancer Specialists - Fairfax /ID# 280415
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Oxfordshire
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Oxford、Oxfordshire、イギリス、OX3 7LE
- 募集
- Oxford University Hospital NHS Trust /ID# 279764
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-
-
-
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Haifa、イスラエル、3109601
- 募集
- Rambam Health Care Campus- Haifa /ID# 279409
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Jerusalem、イスラエル、91120
- 募集
- Hadassah Medical Center-Hebrew University /ID# 279411
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Tel Aviv
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Ramat Gan、Tel Aviv、イスラエル、5265601
- 募集
- The Chaim Sheba Medical Center /ID# 279408
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Tel Aviv、Tel Aviv、イスラエル、6423906
- 募集
- Tel Aviv Sourasky Medical Center /ID# 279414
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Victoria
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Melbourne、Victoria、オーストラリア、3084
- 募集
- Austin Hospital /ID# 280283
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Lisbon、ポルトガル、1649-035
- 募集
- Unidade Local de Saude de Santa Maria /ID# 279884
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Lisbon District
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Lisbon、Lisbon District、ポルトガル、1400-038
- 募集
- Fundacao Champalimaud /ID# 279881
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Kaohsiung City、台湾、807
- 募集
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 279735
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Taichung、台湾、40447
- 募集
- China Medical University Hospital /ID# 279725
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Taipei、台湾、112
- 募集
- Taipei Veterans General Hospital /ID# 279726
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Tokyo
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Koto-ku、Tokyo、日本、135-8550
- 募集
- The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 280140
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Seoul Teugbyeolsi
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Seoul、Seoul Teugbyeolsi、韓国、03080
- 募集
- Seoul National University Hospital /ID# 280191
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参加基準
適格基準
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
Inclusion Criteria:
- Have unresectable, metastatic histologically- or cytologically-confirmed adenocarcinoma of the pancreas
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Must consent to provide archived or recently obtained tumor tissue during Screening
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion Criteria:
- Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting
- Prior c-MET targeting therapy
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.
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：順次割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Ph 2: Dose Escalation Telisotuzumab Adizutecan + FOLFOX
Participants will receive Telisotuzumab Adizutecan + fluorouracil, folinic acid, and oxaliplatin (FOLFOX) until doses for optimization are determined, as part of an approximately 2 year study period. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
|
実験的：Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose A
Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose A as part of the approximately 2 year study duration. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
|
実験的：Ph 2: Dose Optimization Telisotuzumab Adizutecan+FOLFOX Dose B
Participants will receive Telisotuzumab Adizutecan+FOLFOX Dose B as part of the approximately 2 year study duration. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
|
アクティブコンパレータ：Ph 2: Dose Optimization Standard of Care (SOC) mFOLFIRINOX
Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
IV Infusion IV Infusion IV Infusion IV Infusion |
|
実験的：Ph 3: Telisotuzumab Adizutecan RP3D + FOLFOX
Participants will receive Telisotuzumab Adizutecan recommended Phase 3 dose (RP3D) + FOLFOX as part of an approximately 2 year study period. |
IV Infusion Intravenous (IV) Infusion IV Infusion IV Infusion |
|
アクティブコンパレータ：Ph 3: SOC mFOLFIRINOX
Participants will receive SOC (fluorouracil, leucovorin, oxaliplatin, and irinotecan) as part of the approximately 2 year study duration. |
IV Infusion IV Infusion IV Infusion IV Infusion |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 2 and Phase 3: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
時間枠：through study completion, approximately 6 years
|
OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1. |
through study completion, approximately 6 years
|
|
Phase 3: Overall Survival (OS)
時間枠：through study completion, approximately 6 years
|
OS is defined as the time from date of randomization to the death from any cause. |
through study completion, approximately 6 years
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 2 and Phase 3: Progression-Free Survival (PFS) assessed by BICR per RECIST v1.1
時間枠：through study completion, approximately 6 years
|
PFS is defined as the time from the date of randomization or date of first dose of study treatment to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. |
through study completion, approximately 6 years
|
|
Phase 2 and Phase 3: Duration Of Response (DoR) assessed by BICR per RECIST v1.1
時間枠：through study completion, approximately 6 years
|
DoR is defined as time from the initial response of Complete Response or Partial Response assessed by BICR per RECIST v1.1 to the first occurrence of radiographic progression assessed by BICR per RECIST v1.1 or death from any cause, whichever occurs first. |
through study completion, approximately 6 years
|
|
Phase 2 and Phase 3: Clinical Benefit (CB) assessed by BICR per RECIST v1.1
時間枠：through study completion, approximately 6 years
|
CB is defined as a participant achieving best overall response of confirmed CR or confirmed PR, or SD (with a minimum duration of 24 weeks) assessed by BICR per RECIST v1.1. |
through study completion, approximately 6 years
|
|
Phase 2 : Overall Survival
時間枠：through study completion, approximately 6 years
|
OS is defined as the time from the date of randomization or date of first dose of study treatment to the event of death from any cause |
through study completion, approximately 6 years
|
|
Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30-item (EORTC QLQ-C30)
時間枠：through study completion, approximately 6 years
|
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
through study completion, approximately 6 years
|
|
Phase 3: Change from baseline and time to deterioration in scale of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Pancreatic Cancer Module (EORTC QLQ-PAN26)
時間枠：through study completion, approximately 6 years
|
The EORTC QLQ-PAN is a PDAC-specific module and consists of 26 questions assessing pancreatic cancer- and treatment-related symptoms and impact, including 7 scales, and 10 single items, All questions employ a one week recall period, and each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
through study completion, approximately 6 years
|
|
Phase 3: Change in Selected items of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
時間枠：through study completion, approximately 6 years
|
The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present). |
through study completion, approximately 6 years
|
|
Phase 3: Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)
時間枠：through study completion, approximately 6 years
|
The FACT GP5 item ("I am bothered by side effects of treatment") is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on patients. This item is rated on a 5- point Likert scale from 0="not at all" to 4="very much." |
through study completion, approximately 6 years
|
|
Phase 3: Change in Selected items of Patient Global Impression of Severity (PGIS)
時間枠：through study completion, approximately 6 years
|
The PGIS scale asks the participant to assess the severity of their PDAC symptoms over the past 7 days and employs a 5-point response scale ranging from "None" to "Very Severe". |
through study completion, approximately 6 years
|
|
Phase 3: Change in Selected items of Patient Global Impression of Change (PGIC)
時間枠：through study completion, approximately 6 years
|
The PGIC scale assesses patients' perceptions of change in their PDAC symptoms since the start of treatment in the study and employs a 7-point response scale ranging from "Much Better" to "Much worse". |
through study completion, approximately 6 years
|
|
Phase 3: Change from baseline in European Quality of Life 5 Dimensions (EQ-5D-5L)
時間枠：through study completion, approximately 6 years
|
The EQ-5D-5L is a generic preference instrument that has been validated in numerous cancer populations. The EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The EQ VAS records the participant's self-rated health on a vertical VAS where 100 represents "The best health you can imagine" and 0 represents "The worst health you can imagine." |
through study completion, approximately 6 years
|
協力者と研究者
捜査官
捜査官
- スタディディレクター：ABBVIE INC.、AbbVie
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
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
その他の研究ID番号
- M25-288
- 2025-522563-15-00 (その他の識別子：EU CT)
- 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?
IPD プランの説明
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 共有時間枠
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 共有アクセス基準
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
米国で製造され、米国から輸出された製品。
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。