OncoMatch/Clinical Trials/NCT05287945
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
Is NCT05287945 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Orellanine for carcinoma, renal cell.
Treatment: Orellanine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Metastatic disease required
advanced ccRCC or pRCC. For patients in the expansion portion of the study only: Measurable disease per RECIST version 1.1 criteria.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immuno-oncology therapy
Immuno-oncology therapy (IO) given in the last six (6) months prior to enrolment
Cannot have received: systemic anti-cancer therapy
Other systemic anti-cancer therapy within 2 weeks before first dose.
Cannot have received: radiation therapy
Radiotherapy within 2 weeks before first dose.
Cannot have received: investigational product
Has received any other investigational product within 4 weeks before first dose.
Lab requirements
Blood counts
Neutrophils ≥1.5 × 10^9/L, without growth factor stimulation within 3 weeks prior to the blood test; platelets ≥100 × 10^9/L; haemoglobin ≥5.6 mmol/L (~90 g/L). Use of erythropoietin or blood transfusions are permitted.
Kidney function
Must be on chronic hemodialysis (on a consistent regimen for the previous three months, with allowance for intermittent treatments as required for volume overload).
Liver function
AST and ALT ≤2.5 × ULN (≤5 × ULN for patients with liver metastases); total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin >1.5 × ULN; for Gilbert's syndrome, total bilirubin ≤2 × ULN is acceptable.
Cardiac function
QTc interval at baseline of <470 msec.
Has acceptable haematologic laboratory values... Has acceptable liver laboratory values... Must be on chronic hemodialysis... QTc interval at baseline of ≥470 msec [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University in St. Louis · St Louis, Missouri
- University of Texas - MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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