Orellanine specifically targets renal clear cell carcinoma.
Lisa Buvall, Heidi Hedman, Alina Khramova...
https://pubmed.ncbi.nlm.nih.gov/29207627Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05287945
A Phase I/II, Open-Label Study on Safety, Tolerability, and Anti-Tumor Effects of Orellanine in Patients with Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
Led by Oncorena AB · Updated on 2026-05-22
75
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary anti-tumor effects of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have not responded to standard treatments. This phase I/II, open-label study focuses on patients with end-stage kidney disease who are on stable chronic hemodialysis. The study is conducted by Oncorena AB and involves up to 75 participants. The trial consists of three parts: Part A involved dose escalation within patients and is now closed. Part B, currently ongoing, explores dose escalation based on exposure time, with patients assigned to either a 24-hour or 72-hour orellanine exposure group defined by hemodialysis timing. Orellanine is given as a 30-minute intravenous infusion once every 28 days. Hemodialysis sessions are timed before and after infusion to control drug elimination. Part C will expand dosing to better characterize safety and antitumor activity at the chosen dose and exposure. Participants will continue their regular hemodialysis schedule throughout the study. Researchers will monitor safety through adverse events, vital signs, laboratory tests, and physical exams over approximately one year. They will also assess orellanine's effect on tumors, pharmacokinetics, and dosing limits. Study visits include regular assessments to track response and tolerability during the treatment cycles and follow-up periods.
CONDITIONS
Brief Title
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Histologically confirmed metastatic clear-cell or papillary renal carcinoma
- Measurable disease per RECIST version 1.1 (for expansion phase only)
- 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, platelets 100 x 10^9/L, hemoglobin 5.6 mmol/L
- Acceptable liver function: AST and ALT 2.5 x ULN (5 x ULN if liver metastases), total bilirubin 1.5 x ULN or direct bilirubin ULN
- On chronic hemodialysis with stable regimen for past 3 months
- Treating doctors agree loss of kidney function from treatment will not significantly affect dialysis
- Agree to use two forms of highly effective contraception during treatment and for specified months after
- Negative pregnancy test for females of child-bearing potential
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Other malignancy diagnosed within 2 years except certain treated skin, breast, cervical, or low-grade prostate cancers
- 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 prior treatment side effects to grade 1 or better except alopecia and grade 2 neuropathy
- Received investigational product within 4 weeks before first dose
- Pregnant or breastfeeding
- Uncontrolled medical conditions or active infections limiting study compliance or increasing risk
- QTc interval at baseline of 470 milliseconds or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive orellanine as a 30 minute intravenous infusion once during each 28 day treatment cycle. Hemodialysis is performed to define the exposure period, which may be 24 or 72 hours depending on the cohort assignment. Participants continue their regular hemodialysis schedule throughout each cycle.
1 infusion visit per 28-day cycle with multiple hemodialysis sessions per cycle
Follow-up
Duration - Up to approximately 1 year through study completion
Participants are monitored for safety, tolerability, and anti-tumor effects after treatment cycles, including assessment of adverse events, laboratory tests, vital signs, and tumor response.
Regular visits for assessments throughout the follow-up period
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
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Research Team
B
Börje Haraldsson, M.D., Ph.D.
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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E A Eisenhauer, P Therasse, J Bogaerts...
https://pubmed.ncbi.nlm.nih.gov/19097774Long-term clinical outcome for patients poisoned by the fungal nephrotoxin orellanine.
Heidi Hedman, Johan Holmdahl, Johan Mölne...
https://pubmed.ncbi.nlm.nih.gov/28372584Current Management Strategy for Metastatic Renal Cell Carcinoma and Future Directions.
Hussein Merza, Marijo Bilusic
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https://pubmed.ncbi.nlm.nih.gov/7165009Cancer statistics, 2018.
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https://pubmed.ncbi.nlm.nih.gov/29313949