Phase III Study of Orellanine Treatment for Metastatic Clear-Cell or Papillary Renal Cell Carcinoma in Patients on Chronic Hemodialysis

What this Trial Is About

Researchers are evaluating the safety, tolerability, and preliminary anti-tumor effects of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have not responded to standard treatments. This phase III, open-label study focuses on patients with end-stage kidney disease who are on stable chronic hemodialysis. The study is conducted by Oncorena AB and involves up to 75 participants. The trial consists of three parts Part A involved dose escalation within patients and is now closed. Part B, currently ongoing, explores dose escalation based on exposure time, with patients assigned to either a 24-hour or 72-hour orellanine exposure group defined by hemodialysis timing. Orellanine is given as a 30-minute intravenous infusion once every 28 days. Hemodialysis sessions are timed before and after infusion to control drug elimination. Part C will expand dosing to better characterize safety and antitumor activity at the chosen dose and exposure. Participants will continue their regular hemodialysis schedule throughout the study. Researchers will monitor safety through adverse events, vital signs, laboratory tests, and physical exams over approximately one year. They will also assess orellanines effect on tumors, pharmacokinetics, and dosing limits. Study visits include regular assessments to track response and tolerability during the treatment cycles and follow-up periods.

Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma