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A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

Primary Purpose

Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
UGN-301
UGN-201
Gemcitabine
Sponsored by
UroGen Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-muscle Invasive Bladder Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able to give informed consent.
  2. Arm A: Have confirmed recurrent NMIBC with HG Ta disease and/or CIS or recurrent IR LG Ta disease.

    Arm B: Have confirmed recurrent NMIBC with HG Ta disease and/or CIS.

  3. 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.
    • Have otherwise failed adequate BCG therapy (eg, recurrence > 6 months [papillary] or > 12 months [CIS] after last BCG exposure).
    • Are BCG intolerant, defined as the inability to tolerate at least one full induction course of BCG.
    • Have HG Ta disease with tumors ≤ 3 cm and failed at least one previous course of therapy (eg, adjuvant intravesical chemotherapy).
  4. Have all papillary tumors visible by white light resected, and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Note: Blue light cystoscopy is not permitted.
  5. Eastern Cooperative Oncology Group (ECOG) status ≤ 2.
  6. Absence of concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma (UC) within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computerized tomography (CT) urogram with or without contrast, or magnetic resonance imaging (MRI) urogram with or without contrast performed within 6 months of enrollment.
  7. Patients with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen < 10 ng/dL, Gleason score 6 and clinical stage tumor-1 are permitted to be in the study at the discretion of the Investigator (see exclusion criterion 9).
  8. Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last administration of study drug and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. "Maximally effective birth control" means that the patient, if sexually active, should be using a combination of 2 methods of birth control that are approved and recognized to be effective by health authorities.
  9. Male patients must be surgically sterile or willing to use 2 highly effective forms of birth control upon enrollment, during the course of the study, and for 1 month following the last study drug instillation.
  10. Has adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests outlined below:

    • Leukocytes ≥ 3,000/μL;
    • Absolute neutrophil count (ANC) ≥ 1,500/μL;
    • Platelets ≥ 100,000/μL;
    • Hemoglobin ≥ 9.0 g/dL;
    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN;
    • Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
    • Estimated creatinine clearance ≥ 30 mL/min calculated using the Cockcroft-Gault equation.
  11. Has a life expectancy > 12 months.

Exclusion Criteria:

  1. Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV).
  2. Current systemic therapy for bladder cancer.
  3. High or low grade T1 disease.
  4. Prior therapy with an anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), anti-programmed cell death 1 (PD-1), anti-PD-ligand 1 (L1) agent, or with an agent directed to another co-inhibitory T-cell receptor.
  5. Active infection requiring systemic therapy including urinary tract infection (once satisfactorily treated, patients can enter the study).
  6. Active systemic autoimmune disease that required systemic treatment in the past 2 years. Short courses of steroids (≤ 14 days) for medical reasons without anticancer intent (eg, atopic dermatitis, psoriasis, infection, allergic reaction) are permitted if the last dose was ≥ 4 weeks before the first dose of study treatment.
  7. Women who are pregnant or nursing.
  8. Any medical psychological, familial, sociological, or geographical condition that, in the opinion of the Investigator, would preclude participation in the study.
  9. History of malignancy of other organ system within the past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathological tumor-2 UTUC at least 24 months after nephroureterectomy. Patients with genitourinary cancers other than UC or prostate cancer that are under active surveillance are also excluded (see inclusion criterion 7).
  10. Patients who cannot tolerate intravesical dosing or intravesical surgical manipulation.
  11. Intravesical therapy within 4 weeks before starting study treatment.
  12. Has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks before the first dose of study treatment.
  13. Has received an immune modulator therapy within 5 half-lives of starting study treatment.
  14. Has received a vaccine within 2 weeks before starting study treatment.
  15. Has a known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Sites / Locations

  • Arkansas UrologyRecruiting
  • UCLA - University of CaliforniaRecruiting
  • Florida Urology Partners, LLCRecruiting
  • Johns Hopkins UniversityRecruiting
  • Manhattan Medical ResearchRecruiting
  • Clinical Research SolutionsRecruiting
  • Penn State Milton S Hershey Medical CenterRecruiting
  • I.R.C.C.S. Ospedale San Raffaele
  • National Tumor Institute Fondazione G. PascaleRecruiting
  • Istituto Oncologico VenetoRecruiting
  • NEXT Oncology IOB- Hospital Quironsalud BarcelonaRecruiting
  • Hospital Clinic de Barcelona Instituto Clinic de Nefrologia y Urologia (ICNU)Recruiting
  • NEXT Oncology- Hospital Quironsalud MardridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

UGN-301 monotherapy dose escalation (Arm A)

UGN-301 dose escalation + UGN-201 combination (Arm B)

UGN-301 dose escalation + gemcitabine combination (Arm C)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
The number of patients with each type of event will be summarized.
Concentration of UGN-301 in blood and urine
Data will be summarized using descriptive statistics.
Complete response rate (CRR)
CRR is defined as the proportion of CIS patients who achieved CR at the Week 12 (3-month) Visit.
Recurrence-free survival (RFS) rate
RFS rate is defined as the proportion of patients with Ta/T1 disease who are recurrence-free at the Week 12 (3-month) Visit.

Secondary Outcome Measures

Presence of anti-drug antibodies (ADA) in serum
The number of patients with ADA will be summarized.
UGN-301 maximum serum concentration (Cmax) following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-301 area under the concentration-time curve (AUC) following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-301 time to maximum serum concentration (tmax) following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-301 terminal half-life (t1/2) following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-301 concentration in serum at the end of a dosing interval (Ctau) following single and repeat dose administration
Data will be summarized using descriptive statistics.
Concentration of UGN-201 and its metabolites in blood and urine
Data will be summarized using descriptive statistics.
UGN-201 Cmax following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-201 AUC following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-201 tmax following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-201 t1/2 following single and repeat dose administration
Data will be summarized using descriptive statistics.
UGN-201 Ctau following single and repeat dose administration
Data will be summarized using descriptive statistics.

Full Information

First Posted
May 5, 2022
Last Updated
August 16, 2023
Sponsor
UroGen Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05375903
Brief Title
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Official Title
A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (Zalifrelimab) Administered Intravesically as Monotherapy and in Combination With Other Agents in Patients With Recurrent NMIBC
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UroGen Pharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with recurrent NMIBC.
Detailed Description
This master protocol will comprise multiple treatment arms designed to independently investigate intravesical delivery of UGN-301 either as monotherapy or in combination with other agents. Initial study treatment arms will include: UGN-301 monotherapy UGN-301 + UGN-201 (imiquimod) in combination UGN-301 + gemcitabine in combination Additional study treatment arms investigating UGN-301 in combination with other agents may be added in the future. The study will evaluate escalating doses of UGN-301 to determine the biologically effective dose (BED) and maximum tolerated dose (MTD) of UGN-301 either as monotherapy or in combination with other agents. When evaluated in combination with other agents, the UGN-301 dose will begin at least 1 dose level lower than the highest dose level cleared in the monotherapy arm, or 1 dose level lower than the RP2D. Eligible patients in each study treatment arm will enter a 12-week Induction Period. Patients with noninvasive papillary carcinoma and/or tumor that invades the lamina propria (Ta and/or T1) who do not have disease recurrence and patients with carcinoma in situ (CIS) who have a complete response (CR) at 3 months after the start of treatment will return to the clinic for a Safety Follow-up Visit at 6 months after the start of treatment. Ta/T1 patients without disease recurrence and CIS patients with CR at 6 months may enter an Optional Maintenance Period of up to 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer, Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UGN-301 monotherapy dose escalation (Arm A)
Arm Type
Experimental
Arm Description
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.
Arm Title
UGN-301 dose escalation + UGN-201 combination (Arm B)
Arm Type
Experimental
Arm Description
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.
Arm Title
UGN-301 dose escalation + gemcitabine combination (Arm C)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
UGN-301
Other Intervention Name(s)
UGN-301 (zalifrelimab) intravesical solution
Intervention Description
Induction Period: Intravesical administration once weekly for 6 weeks. Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment).
Intervention Type
Drug
Intervention Name(s)
UGN-201
Other Intervention Name(s)
UGN-201 (imiquimod) intravesical solution
Intervention Description
Induction Period: Intravesical administration once weekly for 6 weeks. Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment).
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Induction Period: Intravesical administration once weekly for 6 weeks. Optional Maintenance Period: Intravesical administration once every 3 months (at 6, 9, and 12 months after the start of treatment).
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
Description
The number of patients with each type of event will be summarized.
Time Frame
Up to 15 months
Title
Concentration of UGN-301 in blood and urine
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
Complete response rate (CRR)
Description
CRR is defined as the proportion of CIS patients who achieved CR at the Week 12 (3-month) Visit.
Time Frame
3 months
Title
Recurrence-free survival (RFS) rate
Description
RFS rate is defined as the proportion of patients with Ta/T1 disease who are recurrence-free at the Week 12 (3-month) Visit.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Presence of anti-drug antibodies (ADA) in serum
Description
The number of patients with ADA will be summarized.
Time Frame
3 months
Title
UGN-301 maximum serum concentration (Cmax) following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-301 area under the concentration-time curve (AUC) following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-301 time to maximum serum concentration (tmax) following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-301 terminal half-life (t1/2) following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-301 concentration in serum at the end of a dosing interval (Ctau) following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
Concentration of UGN-201 and its metabolites in blood and urine
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-201 Cmax following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-201 AUC following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-201 tmax following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-201 t1/2 following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks
Title
UGN-201 Ctau following single and repeat dose administration
Description
Data will be summarized using descriptive statistics.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to give informed consent. Arm A: Have confirmed recurrent NMIBC with HG Ta and/or T1 disease and/or CIS or recurrent IR LG Ta and/or T1 disease. Arm B: Have confirmed recurrent NMIBC with HG Ta and/or T1 disease and/or CIS. Arm C: Have confirmed recurrent NMIBC with HG Ta and/or T1 disease and/or CIS. Patients with HG Ta and/or T1 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/T1 disease within 12 months of completion of adequate BCG therapy, or 2) recurrent HG Ta/T1 disease within 6 months of completion of adequate BCG therapy, or 3) HG T1 disease at the first evaluation following a BCG induction course. Notes: Adequate BCG therapy is defined as at least 5 of 6 doses of an initial induction course plus 1) at least 2 of 3 doses of maintenance therapy or 2) 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. Have otherwise failed adequate BCG therapy (eg, recurrence > 6 months [papillary] or > 12 months [CIS] after last BCG exposure). Are BCG intolerant, defined as the inability to tolerate at least one full induction course of BCG. Have HG Ta disease with tumors ≤ 3 cm and failed at least one previous course of therapy (eg, adjuvant intravesical chemotherapy). Have all papillary tumors visible by white light resected, and obvious areas of CIS fulgurated during Screening or within 6 weeks before Screening. Note: Blue light cystoscopy is not permitted. Eastern Cooperative Oncology Group (ECOG) status ≤ 2. Absence of concomitant upper tract urothelial carcinoma (UTUC) or urothelial carcinoma (UC) within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computerized tomography (CT) urogram with or without contrast, or magnetic resonance imaging (MRI) urogram with or without contrast performed within 6 months of enrollment. Patients with prostate cancer on active surveillance at very low, low, or intermediate risk for progression, defined as Gleason Grade Group 1 or 2, Gleason score ≤ 7, with prostate-specific antigen < 20 ng/dL, and cT1-cT2b (NCCN, 2023) are permitted to be in the study at the discretion of the investigator (see exclusion criterion 8). Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last administration of study drug and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. "Maximally effective birth control" means that the patient, if sexually active, should be using a combination of 2 methods of birth control that are approved and recognized to be effective by health authorities. Male patients must be surgically sterile or willing to use 2 highly effective forms of birth control upon enrollment, during the course of the study, and for 1 month following the last study drug instillation. Has adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests outlined below: Leukocytes ≥ 3,000/μL; Absolute neutrophil count (ANC) ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9.0 g/dL; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN; Estimated creatinine clearance ≥ 30 mL/min calculated using the Cockcroft-Gault equation. Has a life expectancy > 12 months. Exclusion Criteria: Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). Current systemic therapy for bladder cancer. Prior therapy with an anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), anti-programmed cell death 1 (PD-1), anti-PD-ligand 1 (L1) agent, or with an agent directed to another co-inhibitory T-cell receptor. Active infection requiring systemic therapy including urinary tract infection (once satisfactorily treated, patients can enter the study). Active systemic autoimmune disease that required systemic treatment in the past 2 years. Short courses of steroids (≤ 14 days) for medical reasons without anticancer intent (eg, atopic dermatitis, psoriasis, infection, allergic reaction) are permitted if the last dose was ≥ 4 weeks before the first dose of study treatment. Women who are pregnant or nursing. 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 other 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 under active surveillance (see inclusion criterion 8). Patients who cannot tolerate intravesical dosing or intravesical surgical manipulation. Intravesical therapy within 4 weeks before starting study treatment. Has participated in a study of an investigational agent and received study therapy or received investigational device within 4 weeks before the first dose of study treatment. Has received an immune modulator therapy within 5 half-lives of starting study treatment. Has received a vaccine within 2 weeks before starting study treatment. Has a known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Lansford
Phone
646-844-6091
Email
heather.lansford@urogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Lentowski
Phone
646-809-2657
Email
christine.lentowski@urogen.com
Facility Information:
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie O'Brien
Phone
501-219-8900
Ext
2002
Email
katie@arkansasurology.com
First Name & Middle Initial & Last Name & Degree
R. Jonathan Henderson, MD
Facility Name
UCLA - University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Chamie, MD
Phone
310-794-5929
Email
kchamie@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Karim Chamie, MD
Facility Name
Florida Urology Partners, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Seibert
Phone
239-223-4488
Email
linda@gulfcoastcta.com
First Name & Middle Initial & Last Name & Degree
Osvaldo Padron, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max Kates, MD
Phone
410-614-0009
Email
mkates@jhmi.edu
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Leanez
Phone
917-409-3919
Email
lleanez@manhattanmedicalresearch.com
First Name & Middle Initial & Last Name & Degree
Jed Kaminetsky, MD
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Simpkins
Phone
440-340-9010
Email
JSimpkins@crssites.com
First Name & Middle Initial & Last Name & Degree
Lawrence Gervasi, MD
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Raman, MD
Email
urologyresearch@pennstatehealth.psu.edu
Facility Name
I.R.C.C.S. Ospedale San Raffaele
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Moschini, MD
Facility Name
National Tumor Institute Fondazione G. Pascale
City
Naples
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Ascierto, MD
Email
p.ascierto@istitutotumori.na.it
Facility Name
Istituto Oncologico Veneto
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Maruzzo, MD PhD
Phone
+39 049.8215953
Email
marco.maruzzo@iov.veneto.it
Facility Name
NEXT Oncology IOB- Hospital Quironsalud Barcelona
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabricio Racca, MD
Phone
(+34) 932 381 661
Email
fracca@nextoncology.eu
Facility Name
Hospital Clinic de Barcelona Instituto Clinic de Nefrologia y Urologia (ICNU)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jose Ribal, MD
Phone
(+34) 932 279 346
Email
mjribal@clinic.cat
Facility Name
NEXT Oncology- Hospital Quironsalud Mardrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Boni, MD
Phone
(+34) 914 521 900
Email
vboni@nextoncology.eu

12. IPD Sharing Statement

Learn more about this trial

A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

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