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Bladder (Urothelial, Transitional Cell) CancerPhase 1NCT07725796

A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC

A Phase 1 study testing UGN-501 in people with Bladder (Urothelial, Transitional Cell) Cancer and NMIBC, run by UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd. at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
UGN-501
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
15 sitesUnited States
Study dates
28 Sep 2026to 2 Aug 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be 18 years of age or older at the time of signing informed consent.
  • Has confirmed recurrent non-muscle invasive bladder cancer (NMIBC) with high-grade Ta and/or T1 disease and/or carcinoma in situ (CIS), or recurrent low-grade Ta and/or T1 disease.
  • Participants with high-grade Ta and/or T1 disease and/or CIS must meet one of the following criteria:
  • Has BCG-unresponsive disease, defined as:
  • persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy; or
  • recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy; or
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  • high-grade T1 disease at the first evaluation following a BCG induction course.
  • Adequate BCG therapy is defined as at least 5 of 6 doses of an initial induction course plus either at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course. Participants with BCG-unresponsive disease also must be unwilling or unfit to undergo radical cystectomy.
  • Is BCG-exposed, defined as high-grade persistent or recurrent NMIBC within 24 months of the last dose of BCG but not meeting the definition of BCG-unresponsive disease, and received at least 5 of 6 doses of an initial induction course of BCG.
  • Is BCG intolerant, defined as the inability to tolerate at least 1 full induction course of BCG.
  • Has a high-grade Ta tumor ≤3 cm and failed at least 1 previous course of therapy, such as TURBT plus an adjuvant induction course of intravesical chemotherapy.
  • Participants with low-grade disease must meet one of the following criteria:
  • Ta tumors recurring within 1 year.
  • Ta solitary tumor >3 cm.
  • Ta multifocal tumors.
  • T1 tumors.
  • All visible papillary tumors must be resected and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Participants with T1 disease should have a re-staging TURBT during Screening or within 6 weeks before Screening. Enhanced cystoscopy, such as blue light cystoscopy or other locally accepted modalities, is permitted, but the same modality must be used for all subsequent disease assessments.
  • Has Eastern Cooperative Oncology Group performance status score ≤2.
  • Has no concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma within the prostatic stroma. Freedom from upper tract disease, if clinically indicated, must be demonstrated by no evidence of upper tract tumor by either IV pyelogram, retrograde pyelogram, CT urogram with or without contrast, MRI urogram with or without contrast, or ureteroscopy with ureteral washing for cytology, performed within 6 months of enrollment. Participants with urothelial carcinoma involving the prostatic urethra, where carcinoma is confined to the ducts and/or epithelium, may be included after a restaging TURBT is performed to rule out more extensive disease involving the prostatic stroma.
  • Participants with prostate cancer may be eligible if, after surgery or radiation, they do not meet criteria for biochemical recurrence, or if they are on active surveillance at very low, low, or favorable risk for progression, defined as Gleason Grade Group 1 or 2, Gleason score ≤7, prostate-specific antigen <20 ng/dL, and cT1-cT2b, at the discretion of the investigator.
  • Has adequate organ and bone marrow function within 14 days of treatment initiation, as determined by routine laboratory tests:
  • Leukocytes ≥3000/μL.
  • Absolute neutrophil count ≥1500/μL.
  • Platelets ≥100,000/μL.
  • Hemoglobin ≥9.0 g/dL.
  • Total bilirubin ≤1.5 × upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) ≤2.5 × ULN.
  • Alanine aminotrasferase (ALT) ≤2.5 × ULN.
  • Alkaline phosphatase ≤2.5 × ULN.
  • Estimated creatinine clearance ≥30 mL/min using the Cockcroft-Gault equation.
  • Has a life expectancy >12 months.
  • Participants and participant partners must agree to follow contraception and barrier method requirements consistent with local regulations and the protocol during the study intervention period and for at least 12 weeks after the last study intervention instillation.
  • Is willing and able to sign informed consent and comply with the requirements and restrictions listed in the informed consent form and protocol.

Who cannot join

  • Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma, including T2, T3, T4, and/or stage IV disease.
  • Current systemic therapy for bladder cancer.
  • Prior treatment with any human adenovirus-based therapy, such as nadofaragene firadenovec-vncg or cretostimogene grenadenorepvec.
  • Intravesical therapy within 4 weeks before starting study intervention, including but not limited to BCG, chemotherapy, and nogapendekin alfa inbakicept.
  • Participation in a study of an investigational agent with receipt of study therapy, or receipt of an investigational device, within 4 weeks before the first dose of study intervention.
  • Receipt of immune modulator therapy within 5 half-lives of starting study intervention, including but not limited to pembrolizumab, BCG, and nogapendekin alfa inbakicept.
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  • Receipt of a vaccine or anti-viral agent within 2 weeks before starting study intervention.
  • Active infection requiring systemic therapy, including urinary tract infection. Participants may enter the study once the infection is satisfactorily treated.
  • Immunocompromised state, including but not limited to HIV infection or any condition that required systemic immunosuppressive treatment in the past 2 years, such as active systemic autoimmune disease or solid organ or stem cell transplant. Short courses (≤14 days) of steroids for medical reasons without anticancer intent, such as atopic dermatitis, psoriasis, infection, or allergic reaction, are permitted if the last dose was at least 4 weeks before the first dose of study intervention.
  • Any medical, psychological, familial, sociological, or geographical condition that, in the opinion of the investigator, would preclude participation in the study.
  • History of malignancy of another organ system within the past 5 years, except previously treated UTUC, basal cell carcinoma or squamous cell carcinoma of the skin, and/or prostate cancer meeting protocol-specified criteria.
  • Cannot tolerate intravesical dosing or intravesical surgical manipulation.
  • Known allergy or hypersensitivity to any of the study interventions or any study intervention excipients.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Heather Lansford contact

610-226-5111

heather.lansford@urogen.com

15 sites in 1 country

United States15 sites, 14 recruiting

  • UPNT Research Institute

    Arlington, Texas, 76017

    Grace Yoon, 817-541-9775, gyoon@folioclinicalresearch.com

    Patrick Collini, MD

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Active, not recruiting

  • Urology Austin

    Austin, Texas, 78759

    Stephanie Sova, 512-788-9688, stephanie.sova@urologyaustin.com

    Brian Mazzarella, MD

    Not yet recruiting

  • Michael G Oefelein Clinical Trials

    Bakersfield, California, 93301

    Swan Kolodji, 661-310-1063, skolodji@folioclinicalresearch.com

    Michael Oefelein, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Nnamdi Onnochie, 857-221-2468, Nnamdi_Onochie@dfci.harvard.edu

    Matthew Mossanen, MD, PhD

    Not yet recruiting

  • University of Miami

    Miami, Florida, 33136

    305-243-2647, archankhandekar@miami.edu

    Archan Khandekar, MD

    Not yet recruiting

  • Urology Center of Southern California

    Murrieta, California, 92563

    Laura Guerrero, 951-677-3000 ext. 309, lguerrero@folioclinicalresearch.com

    Madhumitha Reddy, DO

    Recruiting

  • START Carolinas

    Myrtle Beach, South Carolina, 29572

    Mary Hoyt, 843-839-1679, mary.hoyt@startresearch.com

    Abhishek Srivastava, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Kacie Flaherty, 402-559-3834, kacie.flaherty@unmc.edu

    Jared Schober, MD

    Not yet recruiting

  • University of Pennsylvania-Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

    Ryan DeBarberie, 215-615-3780, ryan.debarberie@pennmedicine.upenn.edu

    Trinity Bivalacqua, MD, PhD

    Not yet recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Jenni McCord, 503-346-1500, mccord@ohsu.edu

    Jen-Jane Liu, MD

    Not yet recruiting

  • East Valley Urology Center of Arizona

    Queen Creek, Arizona, 85140

    Alekya Padavala, 480-525-7998, apadavala@folioresearch.com

    Harpreet Wadhwa, MD

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

    Nicholas Carusone, 315-464-5296, carusonn@upstate.edu

    Joseph Jacob, MD

    Not yet recruiting

  • Renovatio Clinical

    The Woodlands, Texas, 77380

    Pablo Villarreal, 713-703-2398, pablo.villarreal@renovatioclinical.com

    Mahran Shoukier, MD

    Recruiting

  • Michigan Institute of Urology

    Troy, Michigan, 48084

    Danielle Osterhout, 248-786-0467 ext. x1257, OsterhoutD@michiganurology.com

    Jason Hafron, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-501 Administered Intravesically in Adult Participants With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2 dose (RP2D).

Read the detailed description

This is a Phase 1, open-label, dose-escalation, multicenter study to investigate the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of UGN-501, a chimeric oncolytic adenovirus, administered intravesically in participants with recurrent NMIBC.

Eligible participants will enter a 12-week Induction Period. Participants with Ta and/or T1 disease who do not have disease recurrence, and participants with carcinoma in situ (CIS) who have a complete response (CR) at Week 12, will enter the Maintenance Period. Disease assessments will be performed every 3 months through Month 15, or until disease recurrence, disease progression, or death, whichever occurs first.

The maximum duration of participation is approximately 15 months.

This master protocol may include multiple study intervention arms designed to independently evaluate UGN-501. Any additional study intervention arms or dose expansions will be added by protocol amendment.

Being tested
UGN-501
Keywords
CIS, Ta bladder cancer, T1 bladder cancer, BCG-unresponsive NMIBC, BCG-exposed NMIBC, BCG-intolerant NMIBC, Intravesical therapy, Oncolytic Virus
Medical subject headings
Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UGN-501Biological

    UGN-501 is administered by intravesical instillation into the bladder. Participants receive 6 once-weekly instillations during the Induction Period. Participants eligible for maintenance receive 3 once-weekly instillations quarterly from Month 3 through Month 12.

Study groups in NCT07725796
Study groupRoleWhat they receive
UGN-501 Dose Escalation (Part 1)ExperimentalDose escalation of UGN-501 in participants with recurrent NMIBC with high grade (HG) Ta and/or T1 disease and/or CIS or recurrent low grade (LG) Ta and/or T1 disease.
Receives: Biological: UGN-501

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)

    The number of participants with each type of event will be summarized.

    Measured: Up to 15 Months

  2. Concentration of UGN-501 in blood and urine

    Data will be summarized using descriptive statistics.

    Measured: Up to 12 Weeks

  3. Complete response rate (CRR)

    CRR is defined as the proportion of CIS participants who achieved CR at the Week 12 (3-month) Visit.

    Measured: 3 Months

  4. Recurrence-free survival (RFS) rate

    RFS rate is defined as the proportion of participants with Ta/T1 disease who are recurrence-free at the 6-month Visit.

    Measured: 6 Months

Secondary outcomes (7)

  1. Presence of anti-drug antibodies (ADA) in serum

    The number of participants with ADA will be summarized.

    Measured: Up to 12 Weeks

  2. UGN-501 maximum concentration (Cmax) following single and repeat dose administration

    Data will be summarized using descriptive statistics

    Measured: Up to 12 Weeks

  3. UGN-501 area under the concentration-time curve (AUC) following single and repeat dose administration

    Data will be summarized using descriptive statistics.

    Measured: Up to 12 Weeks

  4. UGN-501 terminal half-life (t1/2) following single and repeat dose administration

    Data will be summarized using descriptive statistics.

    Measured: Up to 12 Weeks

  5. UGN-501 time to maximum concentration (tmax) following single and repeat dose administration

    Data will be summarized using descriptive statistics.

    Measured: Up to 12 Weeks

  6. UGN-501 concentration at the end of a dosing interval (Ctau) following single and repeat dose administration

    Data will be summarized using descriptive statistics.

    Measured: Up to 12 Weeks

  7. Evaluation of viral shedding in urine following singe and repeat dose administration.

    Data will be summarized using descriptive statistics.

    Measured: Up to 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study start28 Sep 2026
  3. Primary completion2 Aug 2029 (estimated)
  4. Study completion2 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07725796
Sponsor's protocol ID
UGN-501-101
Status last verified
Oct 2026
First submitted
21 Jul 2026
Last updated
13 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UGN-501 in people with Bladder (Urothelial, Transitional Cell) Cancer and NMIBC, run by UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heather Lansford (610-226-5111, heather.lansford@urogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) (time frame: Up to 15 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07725796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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