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Erdafitinib Intravesical Delivery System · 2 trials · 3 indications
Number of participants with DLT will be assessed. The DLTs are specific adverse events related to erdafitinib intravesical delivery system and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
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.
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.
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.
Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation: Erdafinitib Intravesical Delivery System | EXPERIMENTAL | Participants with bladder cancer and fibroblast growth factor receptor (FGFR) mutations or fusions will receive erdafitinib intravesical delivery system and study will evaluate 2 dose levels of erdafitinib. Participants with a complete response (CR) may continue to receive treatment up to a duration of 1 year as long as there is no disease recurrence or progression, intolerable toxicity or withdrawal of consent. |
| Part 1: Dose Escalation | EXPERIMENTAL | 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. |
| Part 2: Dose Expansion | EXPERIMENTAL | 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. |
| Part 3: RP2D Dose Expansion | EXPERIMENTAL | 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. |
| Part 4: Phase 2 Expansion | EXPERIMENTAL | Participants with recurrent IR-NMIBC will be enrolled in this part to further evaluate the safety, efficacy, and PK of the selected RP2D. |
| Name | Type | Description |
|---|---|---|
| Erdafitinib Intravesical Delivery System | DRUG | Erdafitinib intravesical delivery system will be administered. |
Inclusion Criteria: * Histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder * All visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy * Confirmed recurrence of non-muscle invasive bladder cancer (NMIBC) a...
Erdafitinib Intravesical Delivery System is an investigational small molecule being developed for non-muscle invasive bladder neoplasms and urinary bladder neoplasms. It is delivered directly into the bladder and is currently in Phase 1 clinical development for these oncology indications.
Erdafitinib Intravesical Delivery System targets fibroblast growth factor receptors FGFR1, FGFR2, FGFR3, and FGFR4. It is a small molecule inhibitor designed to block these receptors, which are involved in cancer cell growth and survival.
Erdafitinib Intravesical Delivery System is being developed by Johnson & Johnson, a company listed on the stock exchange under the ticker JNJ. The drug is currently in Phase 1 clinical trials for bladder cancer indications.
Erdafitinib Intravesical Delivery System is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are currently active but not recruiting participants.
Erdafitinib Intravesical Delivery System is being studied in two Phase 1 trials: NCT05316155, a study for localized bladder cancer with 235 participants across multiple countries, and NCT05567185, a study in Japanese participants with bladder cancer enrolling 5 participants.
Erdafitinib Intravesical Delivery System is a formulation of erdafitinib, a small molecule FGFR inhibitor, designed for intravesical delivery directly into the bladder. This delivery system is being studied specifically for localized bladder cancer, whereas erdafitinib may be used in other contexts.