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Non-Muscle Invasive Bladder NeoplasmsPhase 1/2NCT05316155

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

A Phase 1/2 study testing Erdafitinib Intravesical Delivery System in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 59 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Muscle Invasive Bladder Neoplasms
What is being tested?
Erdafitinib Intravesical Delivery System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
59 sitesin 8 countries
Study dates
11 Apr 2022to 24 Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

59 sites in 8 countries.

59 sites in 8 countries

United States25 sites

  • Urology Austin

    Austin, Texas, 78745

  • University of Alabama at Birmingham - The Kirklin Clinic

    Birmingham, Alabama, 35294

  • Levine Cancer Institute, Carolinas HealthCare System

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

  • Urology of Indiana

    Greenwood, Indiana, 46143

  • Hackensack University Medical Center Urology

    Hackensack, New Jersey, 07601

  • Urological Research Network

    Hialeah, Florida, 33016

  • Southern Urology LLC

    Lafayette, Louisiana, 70508

  • Advanced Urology Institute

    Largo, Florida, 33771

  • University of Kentucky

    Lexington, Kentucky, 40506

  • Urology Associates of Denver

    Lone Tree, Colorado, 80124

  • University of Southern California

    Los Angeles, California, 90033

  • Urologic Specialists of Northwest Indiana

    Merrillville, Indiana, 46410

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates

    Nashville, Tennessee, 37209

  • Low Country Urology Clinics

    North Charleston, South Carolina, 29406

  • Advent Health Orlando

    Orlando, Florida, 32804

  • Advanced Urology Institute 1

    Oxford, Florida, 34484

  • Greater Boston Urology

    Plymouth, Massachusetts, 02360

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • Specialty Clinical Research of St Louis

    St Louis, Missouri, 63141

  • Associated Medical Professionals

    Syracuse, New York, 13210

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Spain8 sites

  • Fund. Puigvert

    Barcelona, 08025

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Germany7 sites

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Urologicum Duisburg

    Duisburg, 47169

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Marien hospital Herne

    Herne, 44625

  • Urologie Neandertal Praxis Mettmann

    Mettmann, 40822

  • Universitatsklinikum Munster

    Münster, 48149

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

South Korea5 sites

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Canada4 sites

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9

  • St Josephs Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Vancouver Prostate Centre Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Israel4 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 3436212

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Japan4 sites

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • Osaka General Medical Center

    Osaka, 558-8558

  • Toyama University Hospital

    Toyama, 930 0194

Other trials in Japan

Netherlands2 sites

  • Radboud Umcn

    Nijmegen, 6525 GA

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

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).

Read the detailed description

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.

Being tested
Erdafitinib Intravesical Delivery System
Keywords
Non-Muscle Invasive Bladder Cancer (NMIBC), Muscle Invasive Bladder Cancer (MIBC)
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erdafitinib Intravesical Delivery SystemDrug

    Also called JNJ-42756493

    Erdafitinib intravesical delivery system will be administered.

Study groups in NCT05316155
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants 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.
Receives: Drug: Erdafitinib Intravesical Delivery System
Part 2: Dose ExpansionExperimentalParticipants 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.
Receives: Drug: Erdafitinib Intravesical Delivery System
Part 3: RP2D Dose ExpansionExperimentalParticipants 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.
Receives: Drug: Erdafitinib Intravesical Delivery System
Part 4: Phase 2 ExpansionExperimentalParticipants with recurrent IR-NMIBC will be enrolled in this part to further evaluate the safety, efficacy, and PK of the selected RP2D.
Receives: Drug: Erdafitinib Intravesical Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts 1 to 3: Number of Participants with Adverse Events (AEs)

    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.

    Measured: Up to approximately 7 years 4 months

  2. Parts 1 to 3: Number of Participants with AEs by Severity

    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.

    Measured: Up to approximately 7 years 4 months

  3. Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

    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.

    Measured: Up to 28 days

  4. Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)

    Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.

    Measured: Up to approximately 7 years 4 months

Secondary outcomes (16)

  1. Parts 1 to 3: Plasma Concentration of Erdafitinib

    Plasma concentration of Erdafitinib will be reported.

    Measured: Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks

  2. Parts 1 to 3: Urine Concentration of Erdafitinib

    Urine concentration of Erdafitinib will be reported.

    Measured: Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks

  3. Parts 1 to 3: Cohorts 1 and 2: Recurrence-Free Survival (RFS)

    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.

    Measured: Up to approximately 7 years 4 months

  4. Parts 1 to 3: Cohort 3 and 5: Complete Response (CR) Rate

    CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.

    Measured: At 3 months

  5. Parts 1 to 3: Cohort 3 and 5: Duration of CR

    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.

    Measured: Up to approximately 7 years 4 months

  6. Parts 1 to 3: Cohort 4: Pathological Complete Response (pCR) Rate

    pCR rate is defined as percentage of participants with no pathologic evidence of intravesical disease (pT0) and no pathologic evidence of nodal involvement (pN0).

    Measured: Up to 8 weeks

  7. Parts 1 to 3: Cohort 4: No Pathologic Evidence of Intravesical Disease (pT0)

    pT0 rate is defined as percentage of participants with no Pathologic Evidence of Intravesical Disease.

    Measured: Up to 8 weeks

  8. Parts 1 to 3: Cohort 4: Rate of downstaging to Less than (<) pT2

    Rate of downstaging to <pT2 is defined as percentage of participants with pT stage <2.

    Measured: Up to 8 weeks

  9. Part 4: Duration of CR (DoCR) in Participants with IR-NMIBC

    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.

    Measured: Up to approximately 7 years 4 months

  10. Part 4: Complete Response (CR) at 3 Months in Participants with IR-NMIBC

    CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy at the first disease evaluation.

    Measured: At Month 3

  11. Part 4: Transurethral Resection of the Bladder Tumor (TURBT)-Free Survival in Participants With IR-NMIBC

    Participants with TURBT-free survival will be reported.

    Measured: Up to approximately 7 years 4 months

  12. Part 4: Number of Participants with Treatment-Emergent Adverse Event (TEAEs) by Severity

    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.

    Measured: Up to approximately 7 years 4 months

  13. Part 4: Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score

    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.

    Measured: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

  14. 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

    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.

    Measured: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

  15. Part 4: Percentage of Participants With Clinically Meaningful Change From Baseline in EORTC-QLQ-C30 Scores

    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.

    Measured: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

  16. Part 4: Percentage of Participants With Clinically Meaningful Change From Baseline in EORTC-QLQ-NMIBC24 Scores

    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.

    Measured: At baseline (Week 0), Weeks 12, 24, 36, 48, and at completion or discontinuation of study treatment (up to approximately 7 years 4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start11 Apr 2022
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion24 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316155
Sponsor's protocol ID
CR109115
Other IDs
42756493BLC1003, 2021-004144-22, 2023-506265-65-00, 2023
Status last verified
Nov 2026
First submitted
30 Mar 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Erdafitinib Intravesical Delivery System in people with Non-Muscle Invasive Bladder Neoplasms, run by Janssen Research & Development, LLC at 59 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Spain, Germany, South Korea, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts 1 to 3: Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 7 years 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05316155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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