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限局性膀胱癌に対するエルダフィチニブ膀胱内送達システムの研究

2026年11月2日 更新者：Janssen Research & Development, LLC

非筋層浸潤性または筋層浸潤性膀胱癌および選択された FGFR 変異または融合の参加者におけるエルダフィチニブ膀胱内送達システム (TAR-210) の第 1 相試験

The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

Bladder cancer is one of the most common malignancy worldwide, and non-muscle invasive (NMIBC) requires intensive regimens of frequent monitoring and local resection (transurethral resection of bladder [TURBT]). This study enrolls participants with non-muscle invasive or muscle invasive bladder cancer with activating fibroblast growth factor receptor (FGFR) mutations or fusions. Erdafitinib is a pan-FGFR inhibitor with demonstrated clinical activity when administered orally in patients with solid tumors, including bladder cancer, with FGFR genetic alterations. The Erdafitinib intravesical delivery system is designed to provide release of Erdafitinib in the bladder to treat localized bladder cancer, while reducing systemic toxicities. The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is approximately up to 7 years 4 months.

研究の種類

介入

入学 (実際)

235

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 - The Kirklin Clinic
    • California
      • Los Angeles、California、アメリカ、90033
        • University of Southern California
    • Colorado
      • Lone Tree、Colorado、アメリカ、80124
        • Urology Associates of Denver
    • Florida
      • Hialeah、Florida、アメリカ、33016
        • Urological Research Network
      • Largo、Florida、アメリカ、33771
        • Advanced Urology Institute
      • Orlando、Florida、アメリカ、32804
        • Advent Health Orlando
      • Oxford、Florida、アメリカ、34484
        • Advanced Urology Institute 1
      • Tampa、Florida、アメリカ、33612
        • H Lee Moffitt Cancer Center
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • Northwestern University
      • Chicago Ridge、Illinois、アメリカ、60415
        • Associated Urological Specialists
    • Indiana
      • Greenwood、Indiana、アメリカ、46143
        • Urology of Indiana
      • Merrillville、Indiana、アメリカ、46410
        • Urologic Specialists of Northwest Indiana
    • Kentucky
      • Lexington、Kentucky、アメリカ、40506
        • University of Kentucky
    • Louisiana
      • Lafayette、Louisiana、アメリカ、70508
        • Southern Urology LLC
    • Massachusetts
      • Plymouth、Massachusetts、アメリカ、02360
        • Greater Boston Urology
    • Missouri
      • St Louis、Missouri、アメリカ、63141
        • Specialty Clinical Research of St Louis
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
        • Hackensack University Medical Center Urology
    • New York
      • Syracuse、New York、アメリカ、13210
        • Associated Medical Professionals
    • North Carolina
      • Charlotte、North Carolina、アメリカ、28204
        • Levine Cancer Institute, Carolinas HealthCare System
    • Ohio
      • Gahanna、Ohio、アメリカ、43230
        • Central Ohio Urology Group
    • South Carolina
      • Myrtle Beach、South Carolina、アメリカ、29572
        • Carolina Urologic Research Center
      • North Charleston、South Carolina、アメリカ、29406
        • Low Country Urology Clinics
    • Tennessee
      • Nashville、Tennessee、アメリカ、37209
        • Urology Associates
    • Texas
      • Austin、Texas、アメリカ、78745
        • Urology Austin
      • San Antonio、Texas、アメリカ、78229
        • Urology San Antonio Research
  • イスラエル
      • Haifa、イスラエル、3109601
        • Rambam Medical Center
      • Haifa、イスラエル、3436212
        • Carmel Medical Center
      • Petah Tikva、イスラエル、4941492
        • Rabin Medical Center
      • Tel Aviv、イスラエル、64239
        • Tel Aviv Sourasky Medical Center
  • オランダ
      • Nijmegen、オランダ、6525 GA
        • Radboud Umcn
      • Utrecht、オランダ、3584 CX
        • UMC Utrecht
  • カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1M9
        • Vancouver Prostate Centre Diamond Health Care Centre
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 2Y9
        • Nova Scotia Health Authority
    • Ontario
      • Hamilton、Ontario、カナダ、L8N 4A6
        • St Josephs Healthcare Hamilton
      • Toronto、Ontario、カナダ、M5G 2M9
        • Princess Margaret Cancer Centre
  • スペイン
      • Barcelona、スペイン、08025
        • Fund. Puigvert
      • Barcelona、スペイン、08036
        • Hosp Clinic de Barcelona
      • Barcelona、スペイン、08035
        • Hosp Univ Vall D Hebron
      • Córdoba、スペイン、14004
        • Hosp Reina Sofia
      • Madrid、スペイン、28041
        • Hosp. Univ. 12 de Octubre
      • Madrid、スペイン、28046
        • Hosp. Univ. La Paz
      • Madrid、スペイン、28040
        • Hosp Univ Fund Jimenez Diaz
      • Valencia、スペイン、46009
        • Instituto Valenciano de Oncologia
  • ドイツ
      • Dresden、ドイツ、01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Duisburg、ドイツ、47169
        • Urologicum Duisburg
      • Frankfurt am Main、ドイツ、60590
        • Universitatsklinikum Frankfurt
      • Herne、ドイツ、44625
        • Marien hospital Herne
      • Mettmann、ドイツ、40822
        • Urologie Neandertal Praxis Mettmann
      • Münster、ドイツ、48149
        • Universitatsklinikum Munster
      • Ulm、ドイツ、89081
        • Universitaetsklinikum Ulm
  • 日本
      • Fukuoka、日本、810 8563
        • National Hospital Organization Kyushu Medical Center
      • Kofu、日本、400-8506
        • Yamanashi Prefectural Central Hospital
      • Osaka、日本、558-8558
        • Osaka General Medical Center
      • Toyama、日本、930 0194
        • Toyama University Hospital
  • 韓国
      • Goyang-si、韓国、10408
        • National Cancer Center
      • Gwangju、韓国、61469
        • Chonnam National University Hospital
      • Seoul、韓国、03080
        • Seoul National University Hospital
      • Seoul、韓国、03722
        • Severance Hospital Yonsei University Health System
      • Seoul、韓国、06591
        • The Catholic University of Korea Seoul St Marys Hospital

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年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

Parts 1-3:

  • Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder
  • For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests
  • Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible
  • Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)
  • Cohorts 2 and 4: Willing and eligible for RC

Part 4:

  • Have histologically confirmed diagnosis of recurrent Intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC) Ta LG tumors
  • Must not have undergone tumor debulking or selective ablation of visible lesions; partial tumor biopsy to confirm diagnosis and provide tissue for biomarker testing is permitted as long as remaining tumor is at least 5 millimeter (mm) in size
  • Must submit tissue and urine for FGFR testing
  • Can have a prior or concurrent second malignancy which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment

Exclusion Criteria:

Parts 1-3:

  • Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium
  • Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor
  • Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis
  • Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system
  • Indwelling urinary catheter. Intermittent catheterization is acceptable

Part 4:

  • Histologically confirmed diagnosis of T1 NMIBC, HR NMIBC (HG/G2 or HG/G3 or CIS) or MIBC, locally advanced, non-resectable, or metastatic urothelial carcinoma at any time prior to enrollment. Previous high grade (HG) disease is accepted as long as diagnosis date is greater than or equal to (>=5) years ago and there is documentation of low grade (LG) Ta thereafter
  • Known allergies, hypersensitivity, or intolerance to any study component or its excipients
  • Has a current diagnosis of newly diagnosed IR-NMIBC
  • Received an investigational treatment for bladder cancer after Transurethral Resection of the Bladder Tumor (TURBT) for the current NMIBC diagnosis or within 4 weeks or the agent/therapy washout period, whichever is longer, before the planned first dose of study treatment, or is currently enrolled in an investigational study
  • Evidence of current bladder perforation by cystoscopy or imaging

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：非ランダム化
  • 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：Part 1: Dose Escalation

Participants with recurrent, bacillus Calmette-Guerin (BCG)-experienced high risk papillary-only Non-Muscle-Invasive Bladder Cancer (NMIBC), refusing or ineligible for radical cystectomy or with recurrent, intermediate-risk NMIBC will receive Erdafitinib Intravesical Delivery System. The dose will be escalated to determine preliminary recommended phase 2 dose(s) (RP2D[s]) for Part 2.
薬：Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

他の名前：
  • JNJ-42756493
実験的：Part 2: Dose Expansion

Participants in each of 5 disease-specific NMIBC or MIBC cohorts may be enrolled at one or more dose levels that have been determined to be safe in Part 1.
薬：Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

他の名前：
  • JNJ-42756493
実験的：Part 3: RP2D Dose Expansion

Participants in 2 of the disease-specific NMIBC cohorts (cohorts 1 and 3) may be enrolled at RP2D to determine the safety, evaluate PK and preliminary clinical activity.
薬：Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

他の名前：
  • JNJ-42756493
実験的：Part 4: Phase 2 Expansion

Participants with recurrent IR-NMIBC will be enrolled in this part to further evaluate the safety, efficacy, and PK of the selected RP2D.
薬：Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

他の名前：
  • JNJ-42756493

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
Parts 1 to 3: Number of Participants with Adverse Events (AEs)
時間枠：Up to approximately 7 years 4 months

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Up to approximately 7 years 4 months
Parts 1 to 3: Number of Participants with AEs by Severity
時間枠：Up to approximately 7 years 4 months

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to approximately 7 years 4 months
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
時間枠：Up to 28 days

Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Up to 28 days
Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)
時間枠：Up to approximately 7 years 4 months

Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.
Up to approximately 7 years 4 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Parts 1 to 3: Plasma Concentration of Erdafitinib
時間枠：Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks

Plasma concentration of Erdafitinib will be reported.
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
Parts 1 to 3: Urine Concentration of Erdafitinib
時間枠：Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks

Urine concentration of Erdafitinib will be reported.
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
Parts 1 to 3: Cohorts 1 and 2: Recurrence-Free Survival (RFS)
時間枠：Up to approximately 7 years 4 months

RFS is defined as the time from start of treatment to the first detection of any new high-grade bladder cancer or upper tract urothelial carcinoma or positive urine cytology.
Up to approximately 7 years 4 months
Parts 1 to 3: Cohort 3 and 5: Complete Response (CR) Rate
時間枠：At 3 months

CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.
At 3 months
Parts 1 to 3: Cohort 3 and 5: Duration of CR
時間枠：Up to approximately 7 years 4 months

Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first.
Up to approximately 7 years 4 months
Parts 1 to 3: Cohort 4: Pathological Complete Response (pCR) Rate
時間枠：Up to 8 weeks

pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).
Up to 8 weeks
Parts 1 to 3: Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0)
時間枠：Up to 8 weeks

pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.
Up to 8 weeks
Parts 1 to 3: Cohort 4: Rate of downstaging to Less than (<) pT2
時間枠：Up to 8 weeks

Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.
Up to 8 weeks
Part 4: Duration of CR (DoCR) in Participants with IR-NMIBC
時間枠：Up to approximately 7 years 4 months

Duration of CR is defined as the time from first documentation of CR until the date of documented recurrence or progression, or death, whichever comes first.
Up to approximately 7 years 4 months
Part 4: Complete Response (CR) at 3 Months in Participants with IR-NMIBC
時間枠：At Month 3

CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy at the first disease evaluation.
At Month 3
Part 4: Transurethral Resection of the Bladder Tumor (TURBT)-Free Survival in Participants With IR-NMIBC
時間枠：Up to approximately 7 years 4 months

Participants with TURBT-free survival will be reported.
Up to approximately 7 years 4 months
Part 4: Number of Participants with Treatment-Emergent Adverse Event (TEAEs) by Severity
時間枠：Up to approximately 7 years 4 months

TEAEs are AEs with onset during the intervention phase or that are a consequence of a pre-existing condition that has worsened since baseline. Severity was assessed using National cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0. Severity grades ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Up to approximately 7 years 4 months
Part 4: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score
時間枠：At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)
Part 4: Change from Baseline in European Organization for the Research and Treatment of Cancer Non-Muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC 24) Score
時間枠：At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)
Part 4: Percentage of Participants With Clinically Meaningful Change From Baseline in EORTC-QLQ-C30 Scores
時間枠：At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status/quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)
Part 4: Percentage of Participants With Clinically Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores
時間枠：At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

EORTC QLQ-NMIBC24 is a 24-item questionnaire for evaluating the HRQoL of participants with non-muscle-invasive bladder cancer. The questionnaire is designed to supplement the QLQ C30 and incorporates 6 multi-item scales and 5 single items. Ratings for each item range from 1 (not at all) to 4 (very much). Higher scores indicated greater severity.
At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

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

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

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)

2022年4月11日

一次修了 (推定)

2028年3月30日

研究の完了 (推定)

2029年7月24日

試験登録日

最初に提出

2022年3月30日

QC基準を満たした最初の提出物

2022年3月30日

最初の投稿 (実際)

2022年4月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年11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11月2日

最終確認日

2026年11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

  • CR109115
  • 42756493BLC1003 (その他の識別子：Janssen Research & Development, LLC)
  • 2021-004144-22 (EudraCT番号)
  • 2023-506265-65-00 (レジストリ識別子：EUCT number)
  • 2023 (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?

はい

IPD プランの説明

The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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。

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