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Light therapy could spare kidneys in rare cancer trial

NCT ID NCT04620239

Disease control Sponsor: Steba Biotech S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study tests a drug called TOOKAD (padeliporfin) that is activated by light to destroy low-grade tumors in the kidney or ureter. About 100 adults with this rare cancer will receive the treatment in two phases, with follow-up for up to 4 years. The goal is to see if the therapy can clear all visible tumors and avoid the need for kidney removal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

89 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

renal pelvis/ureter urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transitional cell cancer of renal pelvis and ureter

Contacts and locations

Locations

  • Albany Medical College

    Albany, New York, 12208, United States

  • CHU de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • HCL Hopital Edouard Herriot

    Lyon, 69437, France

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de A Coruña

    A Coruña, 15006, Spain

  • Keck School of Medicine at USC Medical Center

    Los Angeles, California, 90033, United States

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Sheba Medical Center

    Ramat Gan, Israel

  • The Johns Hopkins Hospital, The Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • The Ohio State University (OSU)

    Columbus, Ohio, 43210, United States

  • The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • University of California - Irvine Medical Center

    Irvine, California, 92868, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Washington

    Seattle, Washington, 98195, United States