Your session is about to expire
← Back to Search
Monoclonal Antibodies
UGN-301 for Bladder Cancer
Phase 1
Recruiting
Research Sponsored by UroGen Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Arm A: Have confirmed recurrent NMIBC with HG Ta disease and/or CIS or recurrent IR LG Ta disease.
Patients with HG Ta disease and/or CIS must meet one of the following criteria: Have Bacillus Calmette-Guérin (BCG)-unresponsive disease, defined as 1) persistent or recurrent CIS alone or with recurrent Ta disease within 12 months of completion of adequate BCG therapy, or 2) recurrent HG Ta disease within 6 months of completion of adequate BCG therapy. Notes: Adequate BCG therapy is defined as at least 5 of 6 doses of an initial induction course plus at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course. Patients with BCG-unresponsive disease also must be unwilling or unfit to undergo radical cystectomy.
Timeline
Screening 7 days
Treatment 6 weeks
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug, and determining what the safe dosage is.
Who is the study for?
This trial is for adults with recurrent non-muscle invasive bladder cancer who have tried BCG therapy without success and are not candidates for or willing to undergo radical cystectomy. They should expect to live more than a year, have no muscle-invasive or metastatic cancer, and be free of certain other cancers in the last five years. Participants must also have proper organ function, not be pregnant or nursing, use effective birth control if applicable, and cannot have autoimmune diseases requiring treatment within the past two years.Check my eligibility
What is being tested?
The study tests UGN-301 (zalifrelimab), alone or with other agents, administered directly into the bladder to determine its safety and optimal dose for Phase 2 trials in patients whose bladder cancer has come back after previous treatments. It's an early-stage trial where doses increase gradually to find out how much can be given safely.See study design
What are the potential side effects?
While specific side effects of UGN-301 aren't listed as it's a new treatment under investigation, similar therapies often cause irritation at the administration site (bladder), potential allergic reactions, flu-like symptoms such as fever and chills, fatigue, urinary issues like discomfort during urination or increased frequency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed case of recurrent bladder cancer.
Select...
My bladder cancer has not responded to BCG treatment and I cannot or do not want to have my bladder removed.
Select...
I cannot tolerate a full course of BCG treatment.
Select...
My bladder cancer is less than 3 cm and treatments before didn’t work.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I don't have cancer in my upper urinary tract or prostate area.
Select...
I am a man who is either surgically sterile or willing to use two effective birth control methods during and for a month after the study.
Select...
My recent blood tests meet the required levels for treatment.
Timeline
Screening ~ 7 days1 visit
Treatment ~ 6 weeks8 visits
Follow Up ~ 12 months4 visits
Screening ~ 7 days
Treatment ~ 6 weeks
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate (CRR)
Concentration of UGN-301 in blood and urine
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
+1 moreSecondary outcome measures
Concentration of UGN-201 and its metabolites in blood and urine
Presence of anti-drug antibodies (ADA) in serum
UGN-201 AUC following single and repeat dose administration
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: UGN-301 monotherapy dose escalation (Arm A)Experimental Treatment1 Intervention
Dose escalation of UGN-301 monotherapy in patients with recurrent NMIBC with high grade (HG) Ta and/or T1 disease and/or CIS or recurrent intermediate risk (IR) low grade (LG) Ta and/or T1 disease.
Group II: UGN-301 dose escalation + gemcitabine combination (Arm C)Experimental Treatment2 Interventions
Dose escalation of UGN-301 in combination with a fixed dose of gemcitabine in patients with recurrent NMIBC with HG Ta and/or T1 disease and/or CIS.
Group III: UGN-301 dose escalation + UGN-201 combination (Arm B)Experimental Treatment2 Interventions
Dose escalation of UGN-301 in combination with a fixed dose of UGN-201 in patients with recurrent NMIBC with HG Ta and/or T1 disease and/or CIS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
UroGen Pharma Ltd.Lead Sponsor
18 Previous Clinical Trials
1,268 Total Patients Enrolled
Sunil Raju, MBBSStudy DirectorUroGen Pharma
2 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken part in a study testing a new medication or device in the past 4 weeks.I can take care of myself and am up and about more than half of my waking hours.I am using or willing to use two effective birth control methods during and for 1 month after treatment, or I am not able to have children.I have not received any vaccines in the last 2 weeks.I cannot tolerate a full course of BCG treatment.I haven't had cancer in other organs except skin cancer or specific urinary cancers in the last 5 years.I have low-risk prostate cancer under active surveillance.I have been treated with specific immune system drugs before.I haven't taken immune therapy recently.I have a confirmed case of high-grade non-muscle invasive bladder cancer that has come back.I have an autoimmune disease but haven't needed treatment for it in the last 2 years, except for short steroid courses.My cancer is classified as T1.All visible tumors have been removed and treated areas of CIS burned away before or during my screening.I am currently receiving treatment for bladder cancer.I am not pregnant or nursing.I have not had bladder treatments within the last 4 weeks.My bladder cancer is less than 3 cm and treatments before didn’t work.You are expected to live for at least one year.I have a confirmed case of recurrent bladder cancer.My bladder cancer returned after BCG therapy.My bladder cancer has not responded to BCG treatment and I cannot or do not want to have my bladder removed.I don't have cancer in my upper urinary tract or prostate area.I am a man who is either surgically sterile or willing to use two effective birth control methods during and for a month after the study.My recent blood tests meet the required levels for treatment.My bladder cancer has spread deeply or to other parts of my body.I do not have any active infections needing treatment.I cannot tolerate treatments directly into my bladder or bladder surgery.You are allergic or sensitive to any of the study drugs or their ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: UGN-301 monotherapy dose escalation (Arm A)
- Group 2: UGN-301 dose escalation + UGN-201 combination (Arm B)
- Group 3: UGN-301 dose escalation + gemcitabine combination (Arm C)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 7 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have studies indicated regarding the security of UGN-301 for human use?
"UGN-301’s safety level was assessed at a 1 due to its status as an early phase trial, meaning there is limited data available validating both efficacy and harmlessness."
Answered by AI
What aims is this medical study hoping to accomplish?
"This 15-month trial aims to measure the concentration of UGN-301 in blood and urine. Secondary metrics include: UGN-301 area under the curve (AUC), number of patients with anti-drug antibodies (ADA) in serum, and maximum serum concentration (Cmax). Descriptive statistics will be utilized for data summarization."
Answered by AI
Are there several medical centers conducting this experiment inside the state?
"This clinical trial is currently recruiting patients from 4 different medical centres, located in New york, Tampa and Middleburg Heights as well as other locations. To reduce travel demands it can be beneficial to choose the closest site when enrolling."
Answered by AI
Are there any openings in this experiment for participants?
"Affirmative, the clinical trial is actively recruiting participants. The initial post was published on June 1st 2022 and has been updated as recently as August 1st this year. 60 patients are currently needed from 4 different sites for enrolment into the program."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Manhattan Medical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 2 Days
Most responsive sites:
- Manhattan Medical Research: < 48 hours
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger