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 40 patients. The study will consist of 2 phases: an intra-patient dose escalation phase, followed by a dose expansion phase. The dose escalation phase is designed to define maximum tolerated dose utilizing 3+3 study design or the dose producing complete response in ≥2 patients and enable a subsequent phase in which safety and efficacy can be measured in a more standardized manner. A safety review will be completed by the Data Review Committee after every dose in every patient in the dose escalation phase to review pharmacokinetics, safety and tolerability data. In the expansion part of the study (phase II), additional patients (≤20) will be recruited and treated at the RP2D to better characterize drug safety, tolerability, and preliminary efficacy.
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. The study will include an intra-patient dose escalation phase, followed by a dose expansion phase.