OncoMatch/Clinical Trials/NCT05287945
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
Is NCT05287945 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT05287945 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immuno-oncology therapy, systemic anti-cancer therapy, radiation therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages