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Studie av Erdafitinib Intravesical Delivery System for lokalisert blærekreft

2. november 2026 oppdatert av: Janssen Research & Development, LLC

Fase 1-studie av Erdafitinib Intravesical Delivery System (TAR-210) hos deltakere med ikke-muskelinvasiv eller muskelinvasiv blærekreft og utvalgte FGFR-mutasjoner eller fusjoner

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).

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

235

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Prostate Centre Diamond Health Care Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St Josephs Healthcare Hamilton
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham - The Kirklin Clinic
    • California
      • Los Angeles, California, Forente stater, 90033
        • University of Southern California
    • Colorado
      • Lone Tree, Colorado, Forente stater, 80124
        • Urology Associates of Denver
    • Florida
      • Hialeah, Florida, Forente stater, 33016
        • Urological Research Network
      • Largo, Florida, Forente stater, 33771
        • Advanced Urology Institute
      • Orlando, Florida, Forente stater, 32804
        • Advent Health Orlando
      • Oxford, Florida, Forente stater, 34484
        • Advanced Urology Institute 1
      • Tampa, Florida, Forente stater, 33612
        • H Lee Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University
      • Chicago Ridge, Illinois, Forente stater, 60415
        • Associated Urological Specialists
    • Indiana
      • Greenwood, Indiana, Forente stater, 46143
        • Urology of Indiana
      • Merrillville, Indiana, Forente stater, 46410
        • Urologic Specialists of Northwest Indiana
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40506
        • University of Kentucky
    • Louisiana
      • Lafayette, Louisiana, Forente stater, 70508
        • Southern Urology LLC
    • Massachusetts
      • Plymouth, Massachusetts, Forente stater, 02360
        • Greater Boston Urology
    • Missouri
      • St Louis, Missouri, Forente stater, 63141
        • Specialty Clinical Research of St Louis
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack University Medical Center Urology
    • New York
      • Syracuse, New York, Forente stater, 13210
        • Associated Medical Professionals
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28204
        • Levine Cancer Institute, Carolinas HealthCare System
    • Ohio
      • Gahanna, Ohio, Forente stater, 43230
        • Central Ohio Urology Group
    • South Carolina
      • Myrtle Beach, South Carolina, Forente stater, 29572
        • Carolina Urologic Research Center
      • North Charleston, South Carolina, Forente stater, 29406
        • Low Country Urology Clinics
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37209
        • Urology Associates
    • Texas
      • Austin, Texas, Forente stater, 78745
        • Urology Austin
      • San Antonio, Texas, Forente stater, 78229
        • Urology San Antonio Research
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Japan
      • Fukuoka, Japan, 810 8563
        • National Hospital Organization Kyushu Medical Center
      • Kofu, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Toyama, Japan, 930 0194
        • Toyama University Hospital
  • Nederland
      • Nijmegen, Nederland, 6525 GA
        • Radboud Umcn
      • Utrecht, Nederland, 3584 CX
        • UMC Utrecht
  • Spania
      • Barcelona, Spania, 08025
        • Fund. Puigvert
      • Barcelona, Spania, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Spania, 08035
        • Hosp Univ Vall D Hebron
      • Córdoba, Spania, 14004
        • Hosp Reina Sofia
      • Madrid, Spania, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spania, 28046
        • Hosp. Univ. La Paz
      • Madrid, Spania, 28040
        • Hosp Univ Fund Jimenez Diaz
      • Valencia, Spania, 46009
        • Instituto Valenciano de Oncologia
  • Sør -Korea
      • Goyang-si, Sør -Korea, 10408
        • National Cancer Center
      • Gwangju, Sør -Korea, 61469
        • Chonnam National University Hospital
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Sør -Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Sør -Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
  • Tyskland
      • Dresden, Tyskland, 01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Duisburg, Tyskland, 47169
        • Urologicum Duisburg
      • Frankfurt am Main, Tyskland, 60590
        • Universitatsklinikum Frankfurt
      • Herne, Tyskland, 44625
        • Marien hospital Herne
      • Mettmann, Tyskland, 40822
        • Urologie Neandertal Praxis Mettmann
      • Münster, Tyskland, 48149
        • Universitatsklinikum Munster
      • Ulm, Tyskland, 89081
        • Universitaetsklinikum Ulm

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andre navn:
  • JNJ-42756493
Eksperimentell: 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.
Legemiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andre navn:
  • JNJ-42756493
Eksperimentell: 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.
Legemiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andre navn:
  • JNJ-42756493
Eksperimentell: 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.
Legemiddel: Erdafitinib Intravesical Delivery System

Erdafitinib intravesical delivery system will be administered.

Andre navn:
  • JNJ-42756493

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parts 1 to 3: Number of Participants with Adverse Events (AEs)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parts 1 to 3: Plasma Concentration of Erdafitinib
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Etterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. april 2022

Primær fullføring (Antatt)

30. mars 2028

Studiet fullført (Antatt)

24. juli 2029

Datoer for studieregistrering

Først innsendt

30. mars 2022

Først innsendt som oppfylte QC-kriteriene

30. mars 2022

Først lagt ut (Faktiske)

7. april 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR109115
  • 42756493BLC1003 (Annen identifikator: Janssen Research & Development, LLC)
  • 2021-004144-22 (EudraCT-nummer)
  • 2023-506265-65-00 (Registeridentifikator: EUCT number)
  • 2023 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere