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

Recruiting Phase 3 Interventional Study
Transitional Cell Cancer of Renal Pelvis and Ureter
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Steba Biotech S.A. · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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…
Contacts

Eyal Morag, MD

+97253 9656070

eyal.morag@impactbiotech.com

CONTACT