A Phase 1-2 Study of Nadofaragene Firadenovec in People With Low-Grade Upper Tract Urothelial Cancer

Full Title

A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects with Low-grade Upper Tract Urothelial Carcinoma (LG-UTUC)

Purpose

Researchers want to see if nadofaragene firadenovec is safe and works well in people with urothelial cancer. The people in this study have low-grade upper tract urothelial cancer (LG-UTUC). LG-UTUC may occur in the inner lining of the ureter (tube that connects the kidney to the bladder). It may also occur within the renal pelvis (inner lining of the kidney). LG-UTUC is therefore similar to bladder cancer, but occurs in a different part of the urinary tract.

Nadofaragene firadenovec is a gene therapy that delivers a copy of a protein called IFNa2b to your kidney. This may help your immune system find and destroy cancer cells. By killing the cancer cells, nadofaragene firadenovec may cause your cancer to stop growing and spreading.

Nadofaragene firadenovec is given into your kidney using a tube inserted through your urethra (which carries urine from your body).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have LG-UTUC and be available to the study researchers for at least 18 months after the first dose of the study treatment.
  • Not have previously received gene therapy.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Jonathan Coleman’s office at 646-422-4432.

Protocol

25-128

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Coleman, Jonathan, MD

Co-Investigators

ClinicalTrials.gov ID

NCT06668493