HER2 発現腫瘍患者におけるザニダタマブの第 2 相研究
治療歴のあるHER2発現固形腫瘍の参加者の治療におけるザニダタマブの有効性と安全性を評価するための第2相、非盲検、多施設共同研究（DiscovHER PAN-206）
The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.
調査の概要
状態
介入・治療
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Clinical Trial Disclosure & Transparency
- 電話番号：215-832-3750
- メール：ClinicalTrialDisclosure@JazzPharma.com
研究場所
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Arizona
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Prescott、Arizona、アメリカ、86301
- 引きこもった
- Arizona Oncology Associates, PC - NAHOA
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Colorado
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Littleton、Colorado、アメリカ、80120
- 募集
- Rocky Mountain Cancer Center
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Florida
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Fort Myers、Florida、アメリカ、33901
- 引きこもった
- Florida Cancer Specialists - South
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Orlando、Florida、アメリカ、32827
- 積極的、募集していない
- Florida Cancer Specialists - Lake Nona
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St. Petersburg、Florida、アメリカ、33705
- 引きこもった
- Florida Cancer Specialists - North
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West Palm Beach、Florida、アメリカ、33401
- 引きこもった
- Florida Cancer Specialists - East
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Illinois
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Chicago Ridge、Illinois、アメリカ、60415
- 引きこもった
- Affiliated Oncologists
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Kansas
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Westwood、Kansas、アメリカ、66205
- 募集
- University of Kansas Cancer Center
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Michigan
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Detroit、Michigan、アメリカ、48201
- 引きこもった
- Barbara Ann Karmanos Cancer Institute
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New York
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Lake Success、New York、アメリカ、11042
- 募集
- Northwell Health Cancer Institute
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New York、New York、アメリカ、10065
- 募集
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Horsham、Pennsylvania、アメリカ、19044
- 引きこもった
- Alliance Cancer Specialists
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Tennessee
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Knoxville、Tennessee、アメリカ、37909
- 引きこもった
- Tennessee Cancer Specialists
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Nashville、Tennessee、アメリカ、37203
- 募集
- SCRI Oncology Partners
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Texas
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Amarillo、Texas、アメリカ、79124
- 引きこもった
- Texas Oncology - West Texas
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Dallas、Texas、アメリカ、75246
- 募集
- Texas Oncology - DFW
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Houston、Texas、アメリカ、77030
- 募集
- MD Anderson Cancer Center
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San Antonio、Texas、アメリカ、78217
- 引きこもった
- Texas Oncology - San Antonio
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Virginia
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Roanoke、Virginia、アメリカ、24014
- 引きこもった
- Blue Ridge Cancer Care
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Kutaisi、グルジア、4600
- 募集
- JSC Vian- Krystyna Kiel Oncology Center
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Tbilisi、グルジア、0144
- 募集
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
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Tbilisi、グルジア、0112
- 募集
- LTD Todua Clinic
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Tbilisi、グルジア、0186
- 募集
- Cancer Research Centre
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Tbilisi、グルジア、0186
- 募集
- LTD Caucasus Medical Centre
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Barcelona、スペイン、08035
- 募集
- Hospital Universitario Vall d'Hebron
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Barcelona、スペイン、08036
- 募集
- Hospital Clinic de Barcelona
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Madrid、スペイン、28034
- 募集
- Hospital Universitario Ramon y Cajal
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Madrid、スペイン、28041
- 募集
- Hospital Universitario 12 de Octubre
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Málaga、スペイン、29010
- 募集
- Hospital Regional Universitario de Malaga - Hospital General
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Valencia、スペイン、46010
- 募集
- INCLIVA, Hospital Clinico Universitario de Valencia
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Las Palmas de Gran Canarias
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Las Palmas、Las Palmas de Gran Canarias、スペイン、35016
- 募集
- Hospital Universitario Insular Gran Canarias
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Navarre
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Pamplona、Navarre、スペイン、31008
- 募集
- Complejo Hospitalario de Navarra
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Seoul、韓国、05505
- 募集
- Asan Medical Center
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Seoul、韓国、13620
- 募集
- Seoul National University Bundang Hospital
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Seoul、韓国、04524
- 募集
- The Catholic University of Korea Seoul St. Mary's Hospital
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Gyeonggi-do
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Suwon、Gyeonggi-do、韓国、10408
- 募集
- National Cancer Center Suwon
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Suwon、Gyeonggi-do、韓国、10408
- 募集
- The Catholic University of Korea St Vincent's Hospital
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Hwasun-Gun
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Hwasun-Eup、Hwasun-Gun、韓国、58115
- 募集
- Chonnam National University Hwasun Hospital
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Seoul
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Gangnam-gu、Seoul、韓国、06351
- 募集
- Samsung Medical Center
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Guro-gu、Seoul、韓国、04524
- 募集
- Korea University Guro Hospital
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Jongno-gu、Seoul、韓国、03080
- 募集
- Seoul National University Hospital
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Seodaemun-gu、Seoul、韓国、03722
- 募集
- Severance Hospital
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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
Inclusion Criteria:
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Is at least 18 years of age inclusive at the time of signing the informed consent
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Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.
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HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
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All participants must have adequate tumor sample for submission to allow central HER2 testing.
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Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Has a life expectancy of at least 3 months, in the opinion of the investigator.
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Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:
- Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
- Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to < Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment > 7 days prior to Cycle 1 Day 1.
- Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
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Adequate organ functions.
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Females of childbearing potential must have a negative pregnancy test result.
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Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion Criteria:
- Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
- Has uncontrolled or significant cardiovascular disease
- Has ongoing toxicity related to prior cancer therapy
- Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
- Has known Human Immunodeficiency Virus (HIV) infection.
- Has active hepatitis B or C infection.
- Has an active SARS-CoV-2 infection.
- Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
- Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
- Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.
- Prior treatment with HER2-targeted therapy (Cohort 1 only).
- Has a history of trauma or major surgery
- Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Received zanidatamab at any time prior to the current study.
- Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
- Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
- Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
- Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：Zanidatamab treatment arm
Eligible participants receiving zanidatamab treatment |
Administered by intravenous (IV) infusion
他の名前：
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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 |
|---|---|---|
|
Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR
時間枠：Up to 2.5 years
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The Independent Central Review (ICR) assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
Up to 2.5 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NCI CTCAE バージョン 5.0 による等級分けによる治療中に発生した有害事象 (TEAE) および重篤な有害事象 (SAE) を報告した参加者の数
時間枠：最長2年半
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最長2年半
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線量低減を受けた参加者の数
時間枠：最長2年半
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最長2年半
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TEAEにより治験治療を中止した参加者の数
時間枠：最長2年半
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最長2年半
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ザニダタマブの血清濃度
時間枠：最長2年半
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最長2年半
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ザニダタマブに対する抗薬物抗体陽性の参加者数
時間枠：最長2年半
|
最長2年半
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患者報告の転帰 - AE の共通用語基準 (PRO-CTCAE) に基づいて、症候性有害事象を報告した参加者の数
時間枠：最長2年半
|
最長2年半
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欧州がん研究治療機構 (EORTC) 項目ライブラリに基づく症候性有害事象を報告した参加者の数
時間枠：最長2年半
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最長2年半
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慢性疾患治療の機能評価一般身体項目 5 (FACIT-GP5) で全体的な副作用の悩みを報告した治療を受けた参加者全体の割合
時間枠：最長2年半
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最長2年半
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慢性疾患治療の機能評価一般身体項目 5 (FACIT-GP5) において、治療中の参加者が高い副作用の悩みを報告した時間の割合
時間枠：最長2年半
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最長2年半
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Duration of Response (DOR) Per RECIST Version 1.1, as assessed by ICR
時間枠：Up to 2.5 years
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ICR assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause. |
Up to 2.5 years
|
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cORR by RECIST Version 1.1, as assessed by Investigator
時間枠：Up to 2.5 years
|
Investigator assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
Up to 2.5 years
|
|
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by Investigator
時間枠：Up to 2.5 years
|
Investigator assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause. |
Up to 2.5 years
|
|
Time to Response (TTR), as assessed by ICR
時間枠：Up to 2.5 years
|
ICR assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1. |
Up to 2.5 years
|
|
Time to Response (TTR), as assessed by Investigator
時間枠：Up to 2.5 years
|
Investigator assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1. |
Up to 2.5 years
|
|
Disease control rate (DCR), as assessed by ICR
時間枠：Up to 2.5 years
|
ICR assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria |
Up to 2.5 years
|
|
Disease control rate (DCR), as assessed by Investigator
時間枠：Up to 2.5 years
|
Investigator assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria |
Up to 2.5 years
|
|
Progression Free Survival (PFS), as assessed by ICR
時間枠：Up to 2.5 years
|
PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by ICR according to RECIST v1.1) or death from any cause, whichever occurs first. |
Up to 2.5 years
|
|
Progression Free Survival (PFS), as assessed by Investigator
時間枠：Up to 2.5 years
|
PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by Investigator according to RECIST v1.1) or death from any cause, whichever occurs first. |
Up to 2.5 years
|
|
Overall Survival (OS)
時間枠：Up to 3.5 years
|
OS is defined as the time in months from the first dosing date to the date of death due to any cause. |
Up to 3.5 years
|
協力者と研究者
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
キーワード
追加の関連 MeSH 用語
- 泌尿生殖器疾患
- 生殖器疾患
- 内分泌系疾患
- 口の病気
- 顎口腔疾患
- 泌尿生殖器腫瘍
- 部位別新生物
- 新生物
- 女性の泌尿生殖器疾患
- 女性の泌尿生殖器疾患と妊娠合併症
- 腸の病気
- 気道疾患
- 組織型別の新生物
- 消化器腫瘍
- 消化器系腫瘍
- 消化器系疾患
- 消化器疾患
- 胃の病気
- 腸の腫瘍
- 直腸疾患
- 子宮の病気
- 生殖器疾患、女性
- 肺疾患
- 内分泌腺腫瘍
- 頭頸部腫瘍
- 膵臓の病気
- 新生物、腺および上皮
- 気道腫瘍
- 胸部腫瘍
- 結腸疾患
- 食道疾患
- 肺新生物
- 卵巣疾患
- 付属器疾患
- 性器腫瘍、女性
- 性腺疾患
- 皮膚疾患
- 乳房の病気
- がん
- がん、気管支原性
- 気管支腫瘍
- 子宮腫瘍
- 唾液腺疾患
- 口の新生物
- 皮膚および結合組織疾患
- 胃の新生物
- 結腸直腸腫瘍
- 食道腫瘍
- 卵巣腫瘍
- 乳房腫瘍
- 膵臓の新生物
- がん、非小細胞肺
- 子宮内膜腫瘍
- がん、移行細胞
- 唾液腺腫瘍
- ザニダタマブ
その他の研究ID番号
- JZP598-206
- 2024-516551-41-00 (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?
IPD プランの説明
In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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。