Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Conditions

• Non-Muscle Invasive Bladder Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erdafitinib Intravesical Delivery System — DRUG
  Erdafitinib intravesical delivery system will be administered.

Study Details

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).

Key Dates

Start date

Apr 11, 2022

Status verified

Jun 2026

Primary completion

Mar 30, 2028

Completion

Jul 24, 2029

Study Design

Enrollment

235 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Parts 1 to 3: Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 7 years 4 months ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (25)

Find similar trials in Birmingham, AL

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