NCT03617003

Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)

Completed Phase 1 Last updated 18 July 2025

What this trial tests

Phase 1 trial testing WST11 mediated vascular targeted phototherapy (VTP) in Upper Tract Urothelial Carcinoma in 30 participants. Completed in 15 July 2025.

Timeline

1 August 2018

Primary endpoint
15 July 2025

15 July 2025

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 August 2018
Primary completion	15 July 2025
Estimated completion	15 July 2025
Sites	1 location across United States

Drugs / interventions tested

• WST11 mediated vascular targeted phototherapy (VTP) — full drug profile →
• Endoscopy

Conditions studied

• Upper Tract Urothelial Carcinoma — all drugs for Upper Tract Urothelial Carcinoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Upper Tract Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test the safety of a combination of the study drug called WST11 and PDT. Photodynamic therapy (PDT) is a type of ablation therapy (treatment which destroys tumor cells) which has been previously approved for the treatment of patients with other cancers. It works by using a drug that is given through the vein and then is activated in the tumor by light administered during endoscopy, which results in destruction of the cancer cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Photodynamic Therapy for the Treatment and Diagnosis of <i>Cancer</i>-A Review of the Current Clinical Status.
   Gunaydin G, Gedik ME, Ayan S. · · 2021 · cited 225× · PMID 34409014 · DOI 10.3389/fchem.2021.686303
2. Trial watch: an update of clinical advances in photodynamic therapy and its immunoadjuvant properties for cancer treatment.
   Penetra M, Arnaut LG, Gomes-da-Silva LC. · · 2023 · cited 36× · PMID 37346450 · DOI 10.1080/2162402x.2023.2226535
3. Vascular targeted photodynamic therapy: A review of the efforts towards molecular targeting of tumor vasculature.
   Mashayekhi V, Hoog CO', Oliveira S. · · 2019 · cited 29× · PMID 33568892 · DOI 10.1142/s1088424619300180
4. Emerging photodynamic/sonodynamic therapies for urological cancers: progress and challenges.
   Hu X, Zhang YS, Liu YC, Wang N, et al · · 2022 · cited 28× · PMID 36195918 · DOI 10.1186/s12951-022-01637-w
5. Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma.
   Yip W, Sjoberg DD, Nogueira LM, Tracey AT, et al · · 2023 · cited 17× · PMID 36724067 · DOI 10.1097/ju.0000000000003202
6. Developments in Vascular-Targeted Photodynamic Therapy for Urologic Malignancies.
   Nogueira L, Tracey AT, Alvim R, Reisz P, et al · · 2020 · cited 14× · PMID 33228126 · DOI 10.3390/molecules25225417
7. Upper Tract Urinary Carcinoma: A Unique Immuno-Molecular Entity and a Clinical Challenge in the Current Therapeutic Scenario.
   Mazzaschi G, Giudice GC, Corianò M, Campobasso D, et al · · 2023 · cited 6× · PMID 36855829 · DOI 10.1177/15330338231159753
8. Intravesical Therapy for Upper Urinary Tract Urothelial Carcinoma: A Comprehensive Review.
   Wang Z, Shi H, Xu Y, Fang Y, et al · · 2023 · cited 3× · PMID 37894387 · DOI 10.3390/cancers15205020