NCT03617003

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

Phase I Study of WST11 Phototherapy for Upper Tract Urothelial Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Upper Tract Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	WST11 mediated vascular targeted phototherapy (VTP)	All patients will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes while patients are under anesthesia during their endoscopy procedure, followed by immediate laser light application.
PROCEDURE	Endoscopy	Endoscopy of the bladder

Timeline

• Start date: 2018-08-01
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2018-08-06
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study