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Transitional Cell Carcinoma

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Mitomycins

Mitomycin

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The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or a nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin).

Instill Jelmyto once weekly for six weeks. For patients with a complete response 3 months after Jelmyto initiation, Jelmyto instillations may be administered once a month for a maximum of 11 additional instillations.

Jelmyto (mitomycin) for pyelocalyceal solution

Anthony Fernandez, PharmD

Brett Johnson, MD

Yair Lotan, MD

The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.

Patients may be enrolled prospectively, at the time of receiving Jelmyto, or after receiving Jelmyto for retrospective data capture and prospective follow up. Patients will be followed until 3 years after the first dose of Jelmyto or death.

Data will be captured to address specific clinical questions and data gaps related to real world use of Jelmyto.

Example clinical questions:

1. How is Jelmyto used in the real world setting?
2. What adverse events (AEs) and at what rates and time points are they observed in the real world setting?
3. What is the disease volume before and after resection/ablation prior to treating with Jelmyto?
4. Did the use of Jelmyto impact clinical decision making and management?
5. What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?
6. What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?
7. What are outcomes for non-responders or partial responders? What are the rates of surgical and therapeutic treatment options received following response assessment, including additional Jelmyto?
8. What was the outcome of patients with solitary kidney and/or chronic kidney disease (CKD)? Did Jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline CKD?
9. What is the rate and timing of bladder cancer occurrence and/or recurrences?

uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto

UroGen Pharma Ltd.

Mitomycin for pyelocalyceal solution

Michael Louie, MD, MPH, MSC

This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.

Named Patient Program for Mitomycin for Pyelocalyceal Solution

Tanner Pharma Group

Transitional Cell Cancer of the Renal Pelvis and Ureter

Gemcitabine

ST-02 is a new gemcitabine formulation for instillation into the upper urinary tract. Eligible participants will be enrolled and receive ST-02 once weekly for six weeks in a retrograde or antegrade fashion at the discretion of the treating urologist.

ST-02 drug instillation into the upper urinary tract (renal pelvis)

ST-02

Dasa Durkotova

Genevive Moreau

Peter Black

Marie-Pier Marie-Pier St-Laurent

Miles Mannas

Peter Black, Dr.

The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat Upper Tract Urothelial Carcinoma (UTUC) in participants who have a low-grade tumor.

The main questions this study aims to answer are:

1. Can ST-02 effectively eradicate UTUC by 3 months?
2. Is ST-02 safe for patients with UTUC?

Participants in this study will receive ST-02, a new formulation with gemcitabine once weekly for six weeks. Gemcitabine is known to be an effective drug in treating urothelial carcinoma. This new formulation will be instilled directly into the upper urinary tract (renal pelvis) and will allow the chemotherapeutic to work locally for an extended period of time. The administration process will be retrograde (via a small catheter inserted up into the kidney, under anesthesia) or antegrade (via a nephrostomy, in the clinic) once weekly for six weeks. Safety and efficacy will be monitored for up to a year after the initial response assessment.

This study is a prospective, multicenter, single-arm, open-label clinical trial assessing the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to chemo-ablate low-grade urothelial carcinoma of the upper urinary tract.

Participants with biopsy confirmed low-grade (LG) upper tract urothelial carcinoma (UTUC) and a tumor of 5 to 15 mm will receive 6 weekly instillations of ST-02.

The primary objective is to evaluate complete response (CR) at 3 months from the first instillation during the primary tumor evaluation (PTE) visit. This is done by ureteroscopy, and cytology, with or without biopsy if a tumor remains. If the participant presents as a CR, they will receive their first maintenance instillation of ST-02. Endoscopic monitoring of the upper tract with ureteroscopy for responders will be performed every 3 months for up to 12 months after CR, and the patient will receive a single instillation of ST-02 if no recurrence is noted each time.

Participants who do not have a CR will be treated by their physician with the standard of care, such as biopsy and laser ablation, and with any additional surgical procedure or treatment as deemed necessary by the Principal Investigator (PI).

The first stage of the trial will enroll 30 patients. If there are 8 or fewer CR among these 30 participants, the study will be stopped. Otherwise, an additional 40 participants will be accrued into phase 3, resulting in a total sample size of 70.

The durability of response, event-free survival, safety, and other outcomes will also be measured.

Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma

A Phase 2/3 Multicenter Trial Evaluating the Safety and Efficacy of ST-02 (Mucoadhesive Gemcitabine Suspension) on Ablation of Urothelial Carcinomas in the Upper Urinary Tract

To evaluate the tumor ablative effect (CR after 3 months) of six instillations of ST-02 in the upper urinary tract of participants with UTUC.

To evaluate the durability of tumor ablative effect 12 months after CR in participants who demonstrated complete response at 3 months after instillation of six doses of ST-02

To evaluate the objective response rate after treatment with ST-02, defined as proportion of participants with Complete Response (CR) or Partial Response (PR) at the PTE Visit

To evaluate the event-free survival after treatment with ST-02

To evaluate the safety and tolerability of instillation of ST-02 in participants with UTUC

To assess the peak concentration of gemcitabine in urine and plasma at 0, 1, 2, 4 and 24 hours after instillation (10 patients, phase 2 only)

To assess the time to maximal concentration of gemcitabine in urine and plasma at 0, 1, 2, 4 and 24 hours after instillation (10 patients, phase 2 only)

To evaluate the rate of nephroureterectomy following instillation of ST-02

To evaluate the proportion of participants with PR whose tumors were considered not endoscopically resectable at baseline but are endoscopically resectable after treatment with ST-02

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto	NCT05874921	Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Canc... Urothelial Carc... Carcinoma, Tran... Transitional Ce...	Jelmyto (mitomy...	18 Years -	UroGen Pharma Ltd.
Named Patient Program for Mitomycin for Pyelocalyceal Solution	NCT05494411	Urothelial Canc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc...	Mitomycin for p...	18 Years -	UroGen Pharma Ltd.
Named Patient Program for Mitomycin for Pyelocalyceal Solution	NCT05494411	Urothelial Canc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc... Urothelial Carc...	Mitomycin for p...	18 Years -	UroGen Pharma Ltd.
Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma	NCT06124976	Urothelial Carc... Transitional Ce...	ST-02	18 Years -	University of British Columbia

Spots Global Cancer Trial Database for urothelial carcinoma of the renal pelvis and ureter