Oncorena AB
A phase I/II, open-label, study to determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have failed standard-of-care therapy. All participants must have end-stage kidney disease and be receiving stable chronic hemodialysis.
This is an open, non-controlled, phase I/II study evaluating the safety, tolerability, and anti-tumor efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal carcinoma. The study will include up to 75 patients and is conducted in 3 parts. The study will consist of 3 parts: Part A - an intra-patient dose escalation part, followed by a dose exposure (Part B), followed by a dose expansion (Part C). Part A, which is now closed, used an intra patient dose escalation design to evaluate safety across multiple dose levels. The study is currently in Part B, an expos…
Inclusion criteria: 1. Has provided written informed consent. 2. Has a diagnosis of histologically confirmed advanced ccRCC or pRCC. No conventional therapy is available or considered appropriate by the treating physician or is declined by the patient. 3. For patients in the expansion portion of the study only: Measurable disease per RECIST version 1.1 criteria. 4. ECOG performance status of 0 - 2. 5. Age ≥18 years. 6. Life expectancy ≥3 months. 7. Has acceptable haematologic laboratory values defined as: 1. Neutrophils ≥1.5 × 10\^9/L, without growth factor stimulation within 3 weeks prio…
Orellanine administered intravenously