92 Participants Needed

UGN-103 for Bladder Cancer

(UTOPIA Trial)

Recruiting at 13 trial locations
KH
RS
Overseen ByRenee Sumlin
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: UroGen Pharma Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is UGN-103 safe for humans?

Research on similar treatments like UGN-101 and UGN-102, which also use mitomycin in a gel form, shows promising safety results in clinical trials for treating certain types of bladder and upper tract cancers. These studies suggest that the gel formulation is generally safe for human use.12345

What makes the drug UGN-103 unique for treating bladder cancer?

UGN-103 is unique because it uses a special gel that turns from liquid to gel at body temperature, allowing it to stick to the bladder lining and slowly release the cancer-fighting drug mitomycin, which may improve its effectiveness compared to traditional treatments that wash out quickly.13456

What data supports the effectiveness of the drug UGN-103 for bladder cancer?

Research on similar treatments like UGN-101 and UGN-102, which are also mitomycin-containing gels, shows promising results in treating low-grade urothelial carcinomas by increasing the time the drug stays in contact with the cancer cells, leading to better outcomes. These treatments have been effective in managing similar types of cancer, suggesting potential effectiveness for UGN-103 in bladder cancer.13457

Who Is on the Research Team?

SR

Sunil Raju, MBBS

Principal Investigator

UroGen Pharma

Are You a Good Fit for This Trial?

This trial is for patients with a type of bladder cancer called low-grade non-muscle invasive bladder cancer (LG-NMIBC). Participants must have had at least one prior episode, may have multiple tumors or a tumor larger than 3 cm, and should show signs of early or frequent recurrence. They need normal blood counts and no high-grade disease in recent tests. Patients must consent to follow the study rules.

Inclusion Criteria

I have signed and agreed to all the terms in the consent form.
My bladder cancer was confirmed with a specific biopsy recently.
I have had bladder cancer before, but not including my current diagnosis.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive UGN-103 instilled in the urinary bladder once weekly for 6 weeks

6 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations every 3 months

12 months
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • UGN-103
Trial Overview The trial is testing UGN-103, which is an updated version of UGN-102. It's given as a treatment directly into the bladder for those with LG-NMIBC. The goal is to see how effective and safe this new formulation is when used by itself in patients.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: UGN-103Experimental Treatment1 Intervention
Patients will receive UGN-103 (75 mg mitomycin) once weekly for 6 weeks (a total of 6 doses).

Find a Clinic Near You

Who Is Running the Clinical Trial?

UroGen Pharma Ltd.

Lead Sponsor

Trials
20
Recruited
1,400+

Published Research Related to This Trial

UGN-101, a novel drug using a sustained-release hydrogel formulation of mitomycin-C, has shown promising results in treating low-grade upper tract urothelial carcinomas (UTUCs), with a 59% complete response rate in the OLYMPUS trial.
The treatment demonstrated a good safety profile, with 68% of patients experiencing only mild to moderate urinary adverse events, suggesting it could become a standard treatment option for UTUCs at risk of relapse.
An evaluation of UGN-101, a sustained-release hydrogel polymer-based formulation containing mitomycin-C, for the treatment of upper urothelial carcinomas.Porta, C., Giannatempo, P., Rizzo, M., et al.[2022]
In a phase 2b trial involving 63 patients with low-grade intermediate-risk nonmuscle-invasive bladder cancer, 65% achieved a complete response after treatment with UGN-102, a mitomycin-containing gel, indicating its efficacy as a non-surgical treatment option.
The treatment demonstrated sustained durability, with 73% of patients remaining disease-free 9 months after achieving a complete response, suggesting that UGN-102 could reduce the need for repeated surgeries in these patients.
Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial.Chevli, KK., Shore, ND., Trainer, A., et al.[2022]
In a phase 3 trial involving 71 patients with low-grade upper tract urothelial carcinoma, 58% achieved a complete response to UGN-101 treatment, with 56% maintaining this response after 12 months, indicating its long-term efficacy.
UGN-101 demonstrated a durable response, with an estimated 82% durability at 12 months, although the treatment was associated with a notable incidence of ureteric stenosis (44%), suggesting careful monitoring for side effects is necessary.
Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report.Matin, SF., Pierorazio, PM., Kleinmann, N., et al.[2022]

Citations

An evaluation of UGN-101, a sustained-release hydrogel polymer-based formulation containing mitomycin-C, for the treatment of upper urothelial carcinomas. [2022]
Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial. [2022]
Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report. [2022]
Efficacy and Safety of Mitomycin Gel (UGN-101) as an Adjuvant Therapy After Complete Endoscopic Management of Upper Tract Urothelial Carcinoma. [2023]
UGN-101 (mitomycin gel): a novel treatment for low-grade upper tract urothelial carcinoma. [2020]
Sustained-release Formulation of Mitomycin C to the Upper Urinary Tract Using a Thermosensitive Polymer: A Preclinical Study. [2022]
Antegrade Instillation of UGN-101 (Mitomycin for Pyelocalyceal Solution) for Low-Grade Upper Tract Urothelial Carcinoma: Initial Clinical Experience. [2022]
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