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Tyrosine Kinase Inhibitor

Erdafitinib Delivery System for Bladder Cancer

Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new way to deliver a drug called Erdafitinib directly into the bladder for patients with certain types of bladder cancer. These patients have genetic changes that make their cancer harder to treat. The drug works by blocking proteins that help the cancer grow. The goal is to find the best dose and see how well it works and how safe it is.

Who is the study for?
This trial is for people with recurrent bladder cancer that hasn't spread into muscle or has just started to. They must have a specific genetic change in their tumor and may or may not have had BCG therapy, depending on the group they're placed in. Surgery should be an option for some participants. Those who've had recent pelvic radiation, certain bladder conditions, permanent urinary catheters, or previous FGFR inhibitor treatments can't join.
What is being tested?
The study is testing Erdafitinib Intravesical Delivery System directly applied inside the bladder. The first part of the trial will find the best dose to use while the second part checks how safe it is at that dose.
What are the potential side effects?
While specific side effects aren't listed here, intravesical therapies can generally cause discomfort during administration, increased frequency of urination, pain when urinating, blood in urine and potential risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohorts 1, 3 and 5: up to 6 months; cohort 2 and 4: up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose-limiting Toxicity (DLT)
Secondary study objectives
Cohort 3 and 5: Complete Response (CR) Rate
Cohort 3 and 5: Duration of CR
Administration, Intravesical
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: RP2D Dose ExpansionExperimental Treatment1 Intervention
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.
Group II: Part 2: Dose ExpansionExperimental Treatment1 Intervention
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.
Group III: Part 1: Dose EscalationExperimental Treatment1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for bladder cancer include surgery, chemotherapy, radiation therapy, and emerging targeted therapies. Surgery, such as radical cystectomy, involves removing the bladder to eliminate cancerous tissue. Chemotherapy uses drugs like cisplatin to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. Emerging targeted therapies, including those studied in clinical trials, focus on specific molecular targets within cancer cells, such as FGFR inhibitors like erdafitinib, to block pathways that promote cancer growth. These treatments are crucial as they offer different mechanisms to control or eradicate cancer, providing options tailored to the patient's specific condition and improving overall outcomes.
[The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
991 Previous Clinical Trials
6,386,740 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
757 Previous Clinical Trials
3,962,540 Total Patients Enrolled

Media Library

Erdafitinib Intravesical Delivery System (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05316155 — Phase 1
Bladder Cancer Research Study Groups: Part 2: Dose Expansion, Part 3: RP2D Dose Expansion, Part 1: Dose Escalation
Bladder Cancer Clinical Trial 2023: Erdafitinib Intravesical Delivery System Highlights & Side Effects. Trial Name: NCT05316155 — Phase 1
Erdafitinib Intravesical Delivery System (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05316155 — Phase 1
~65 spots leftby Mar 2028