Actively Recruiting
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
Led by Oncorena AB · Updated on 2026-04-24
75
Participants Needed
5
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Diagnosed with advanced histologically confirmed clear-cell or papillary renal cell carcinoma
- No available or appropriate conventional therapy, or declined standard treatment
- For expansion phase: measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- Age 18 years or older
- Life expectancy of at least 3 months
- Acceptable blood counts: neutrophils ≥1.5 x 10^9/L without recent growth factors, platelets ≥100 x 10^9/L, hemoglobin ≥5.6 mmol/L
- Acceptable liver function: AST and ALT ≤2.5 times upper limit of normal (ULN), or ≤5 times ULN if liver metastases present; total bilirubin ≤1.5 x ULN or direct bilirubin ≤ULN; for Gilbert's syndrome, total bilirubin ≤2 x ULN
- On stable chronic hemodialysis regimen for at least 3 months
- Treating nephrologist and oncologist agree that loss of residual kidney function will not significantly change chronic dialysis treatment
- Use of two forms of effective contraception during treatment and for at least 3 months after last dose for males and 6 months for females of child-bearing potential
- Negative serum pregnancy test for females of child-bearing potential at screening
- Willing and able to comply with travel, visits, treatment, assessments, and study procedures
You will not qualify if you...
- Any other malignancy diagnosed within 2 years prior to enrollment except certain treated skin cancers, superficial melanoma, carcinoma in situ of breast or cervix, or low-grade prostate cancer under surveillance
- Radiotherapy within 2 weeks before first dose
- Immuno-oncology therapy within 6 months before enrollment
- Other systemic anti-cancer therapy within 2 weeks before first dose
- Not recovered from adverse events related to prior cancer medications to at least grade 1 by CTCAE v5.0 except alopecia and grade 2 neuropathy
- Received any investigational product within 4 weeks before first dose
- Pregnant or breastfeeding women
- Uncontrolled medical conditions including active infection or psychiatric/social issues limiting compliance or increasing risk
- QTc interval at baseline of 470 milliseconds or longer
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
2
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
3
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
START Lisbon - Hospital de Santa Maria Av
Lisbon, Portugal, 1649-035
Actively Recruiting
5
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
Research Team
B
Börje Haraldsson, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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