New bladder cancer drug delivery system tested in small japanese study
NCT ID NCT05567185
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This early-stage study tests a new treatment called TAR-210 in 5 Japanese patients with a type of bladder cancer that has specific genetic changes (FGFR mutations). The treatment is placed directly into the bladder to deliver the drug erdafitinib. The main goal is to see if it is safe and tolerable, and to measure how much of the drug gets into the blood and urine.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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5 people
The number who actually took part.
- Started
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Mar 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) after prior therapy that meet either one: a. Recurrence of high-risk NMIBC (high-grade Ta or any-grade T1) within 12 months after adequate Bacillus Calmette-Guerin (BCG), or any-grade T1 within 3 months after 1st induction course, refusing or ineligible for radical cystectomy (RC). b. Recurrence of intermediate- or high-risk NMIBC (any-grade Ta/T1) after prior BCG regardless of the timing of recurrence, refusing or ineligible for RC and considering no other effective treatment options. c. Recurrence of intermediate-risk NMIBC (low grade Ta) after intravesical chemotherapy including maintenance therapy following a single dose after operation, no other effective intravesical chemotherapy is available and refusing BCG treatment * At least 1 of the study protocol defined activating fibroblast growth factor receptors (FGFR) mutation or fusion, as determined by local or central testing using either tumor tissue or urine sample collected prior to trans urethral resection of bladder tumour (TURBT) * Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (\<=) 2 Exclusion Criteria: * Histologically confirmed muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder. * Prior treatment with an fibroblast growth factor receptor (FGFR) inhibitor * Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of erdafitinib intravesical delivery system * Participants with active bladder stones or history of bladder stones less than \[\< 6\] months prior to the start of study treatment * Participants have concurrent or second malignancy other than the disease which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s); -Bladder post-void residual volume (PVR) \>350 mL after second voided urine, -Current central serous retinopathy or retinal pigment epithelial detachment of any-grade
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Osaka International Cancer Institute
Osaka, 541 8567, Japan
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St Marianna University Hospital
Kanagawa, 216 8511, Japan
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Toyama University Hospital
Toyama, 930-0194, Japan
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University of Tsukuba Hospital
Tsukuba, 305 8576, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A pill instead of surgery? trial tests vepugratinib against Low-Grade bladder cancer
- Can heated saline during bladder surgery stop tumors from coming back?
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?