Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Phase 3

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

NCT04620239 · tracked via the Priya Life Science Germany tracker
Sponsor
Steba Biotech S.A
Phase
Phase 3
Started
2021-03-22
Last updated
2026-07-30

Condition(s) studied

Transitional Cell Cancer of Renal Pelvis and Ureter

Investigational drug(s) / intervention(s)

padeliporfin VTP

padeliporfin VTP: During treatment, placement at the target area of an optical light fiber, through the working channel of the ureteroscope. Intravenous administration of padeliporfin at the dose of 3.66 mg/kg infused over 10 minutes. Each target area will be illuminated for 10 minutes.

Study summary

This is a phase 3, open label, single arm study of padeliporfin in the treatment of Upper Tract Urothelial Carcinoma (UTUC). The ENLIGHTED study will recruit patients with low-grade non-invasive upper tract urothelial carcinoma in either the kidney or the ureter. Patients will be treated with padeliporfin VTP in two phases: an Induction Treatment Phase and a Maintenance Treatment Phase and will be followed up for up to an additional 48 months in the long term (non intervention) follow up phase with the specific duration depending on the patient's response to treatment

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male and female patients 18 years or older * Able to understand and provide written informed consent and willing to comply with all tests and procedures associated with the study * New or recurrent low-grade, non-invasive UTUC disease * Biopsy-proven disease . A concurrence of the central pathology reader will be required for eligibility. * Up to 2 biopsy-proven sites of low-grade involvement with the largest tumor (index tumor) between 5 mm and 15 mm in diameter (as measured by endoscopy), both located in the calyces,renal pelvis or in the ureter of the ipsilateral kidney, with an absence of high-grade cells on cytology. (Ureter involvement should be in one anatomical location with no more than 20 mm of contiguous ureteral length) * Karnofsky Performance Status ≥ 50% * Adequate organ function defined at baseline as: * ANC ≥1,000/ μl, * Platelets ≥75,000/ μl, Hb ≥9 g/dl, * INR ≤ 2 * Estimated glomerular giltration rate (eGFR) ≥30 ml/min (using CKD-EPI Method) * Total serum bilirubin \<3 mg/dL, AST/ALT ≤5× upper limit of normal Exclusion Criteria: * Current high-grade or muscle invasive (\>pT1) urothelial carcinoma of the bladder * Carcinoma in situ (CIS) current or previous in the upper urinary tract * History of invasive T2 or higher urothelial cancer in past 2 years * Participation in another clinical study involving an investigational product within 1 month before study entry * BCG or local chemotherapy treatment (including VEGF-targeted therapy) in the upper urinary tract within 2 months prior to inclusion * Systemic chemotherapy treatment (including VEGF-targeted therapy) within 2 months prior to enrollment * Prohibited medication that could not be adjusted or discontinued prior to study treatment • Patients with photosensitive skin diseases or porphyria * Any other medical or psychiatric co-morbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary or liver disease or current heavy smoker that, in the opinion of the study investigator, would make the patient a poor candidate for the study * Pregnant or breast-feeding women.Women of childbearing potential (WOCBP) must undergo a negative serum pregnancy test prior to study entry. * Men and women of reproductive potential not willing to observe conventional and effective birth control for the duration of treatment and for 90 days following the last padeliporfin VTP treatment.

Primary outcome measure(s)

  • Number of patients with absence of UTUC tumors in the entire ipsilateral calyces, renal pelvis and ureter — 28 +/- 3 days post last treatment
    Primary efficacy outcome is the absence of UTUC tumors in the entire ipsilateral calyces renal pelvis and ureter on endoscopic evaluation at the time of Primary Response Evaluation (PRE) (28 +/- 3 days post last treatment) during padeliporfin VTP induction treatment phase. This outcome will be determined dichotomously as either failure or success in achieving complete response. · Complete Response will be defined as absence of disease based on: * absence of visual tumor on endoscopy * no evidence of tumor on biopsy (if feasible) * negative urinary cytology by instrumented collection

Trial sites (18)

FacilityCityRegionStatus
University of California - Irvine Medical Center Irvine California
Keck School of Medicine at USC Medical Center Los Angeles California
Emory University Hospital Atlanta Georgia
The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center Baltimore Maryland
Albany Medical College Albany New York
Memorial Sloan Kettering Cancer Center New York New York
The Ohio State University (OSU) Columbus Ohio
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center Hershey Pennsylvania
Medical University of South Carolina (MUSC) Charleston South Carolina
Carolina Urologic Research Center Myrtle Beach South Carolina
University of Texas Southwestern Medical Center Dallas Texas
University of Washington Seattle Washington
CHU de Lille - Hopital Claude Huriez Lille France
HCL Hopital Edouard Herriot Lyon France
Universitaetsklinikum Tuebingen Tübingen Germany
Sheba Medical Center Ramat Gan Israel
Hospital Universitario de A Coruña A Coruña Spain
Hospital Universitario Vall d'Hebron Barcelona Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04620239 on ClinicalTrials.gov ↗ ← All trials in Germany