NCT05287945

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

A Phase I/II, Open-Label, Single-Arm Study on Safety, Tolerability and Anti-Tumour Efficacy of Orellanine Treatment in Patients With Metastatic Clear-Cell or Papillary Renal Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Oncorena AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The phase I 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).

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Orellanine	Orellanine administered intravenously

Timeline

• Start date: 2023-08-04
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2022-03-18
• Last updated: 2026-03-03

Locations

3 sites across 2 countries: United States, Sweden