Carcinoma, Renal CellPhase 1/2NCT05287945
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
A Phase 1/2 study testing Orellanine in people with Carcinoma, Renal Cell, run by Oncorena AB at 10 sites in 5 countries.
Trial 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 who have failed standard-of-care therapy. All participants must have end-stage kidney disease and be receiving stable chronic hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Orellanine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 4 Aug 2023to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided written informed consent.
- Has a diagnosis of histologically confirmed advanced ccRCC or pRCC. No conventional therapy is available or considered appropriate by the treating physician or is declined by the patient.
- For patients in the expansion portion of the study only: Measurable disease per RECIST version 1.1 criteria.
- ECOG performance status of 0 - 2.
- Age ≥18 years.
- Life expectancy ≥3 months.
Show all 19Show fewer
- Has acceptable haematologic laboratory values defined as:
- 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.
- Has acceptable liver laboratory values defined as:
- Aspartate aminotransferase (AST) and alanine aminotransferase (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 levels >1.5 × ULN
- For patients diagnosed with Gilbert's syndrome, total bilirubin ≤2 × ULN is acceptable.
- Must be on chronic hemodialysis (on a consistent regimen for the previous three months, with allowance for intermittent treatments as required for volume overload).
- The patient's treating nephrologist and oncologist agree that the prospect of loss of remaining renal function resulting from this treatment will not significantly change the patient's future and chronic dialysis treatment.
- Female patients of child-bearing potential and male patients must agree to use 2 forms of highly effective contraception for the duration of study treatment and after the last dose of orellanine for at least 3 months for males and 6 months for females.
- For females of child-bearing potential, a negative serum pregnancy test at screening.
- Patients who are willing and able to comply with travel requirements, scheduled visits, treatment schedule, efficacy assessments, laboratory tests, and other study procedures.
Who cannot join
- Diagnosis of any other malignancy within 2 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, superficial melanoma, or carcinoma in situ of the breast or of the cervix, or low grade (Gleason 7 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration)
- Radiotherapy within 2 weeks before first dose.
- Immuno-oncology therapy (IO) given in the last six (6) months prior to enrolment
- Other systemic anti-cancer therapy within 2 weeks before first dose.
- Has not recovered from AEs due to prior anti-cancer medications to at least grade 1 by CTCAE version 5.0 (except for alopecia and grade 2 neuropathy).
- Has received any other investigational product within 4 weeks before first dose.
Show all 9Show fewer
- Pregnant or breastfeeding women.
- Uncontrolled medical condition including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, or would, in the opinion of the investigator, place the patient at increased risk.
- QTc interval at baseline of ≥470 msec.
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Oncorena Study General Inquiries contact
10 sites in 5 countries
United States6 sites, 6 recruiting
- Recruiting
Roswell Park Comprehensive
Buffalo, New York, 14263
M.D. 716-845-2300 ext. 8313, Saby.George@roswellpark.org
Saby George, MD
- Recruiting
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Nizar Tannir, M.D., 713-563-7265, ntannir@mdanderson.org
Nizar Tannir, M.D.
- Recruiting
University of California Irvine
Orange, California, 92868
Nataliya Mar, M.D., 714-456-5153, marn@hs.uci.edu
Nataliya Mar, M.D.
- Recruiting
Stanford
Palo Alto, California, 94304
Sandhya Srinivas, M.D., 650-498-6000, sandysri@stanford.edu
Sandhya Srinivas, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Arpita Desai, M.D., 415-476-4616, arpita.desai@ucsf.edu
Arpita Desai, M.D.
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Melissa Reimers, M.D., 314-273-3713, mreimers@wustl.edu
Melissa Reimers, MD
France1 site, 1 recruiting
- Recruiting
Institut de Cancerologie Gustave-Roussy
Villejuif, 94805
Christophe Massard, M.D., Ph.D, +33142114211, Christophe.massard@gustaveroussy.fr
Christophe Massard, M.D., Ph.D.
Portugal1 site, 1 recruiting
- Recruiting
START Lisbon - Hospital de Santa Maria Av
Lisbon, 1649-035
Andre Mansinho, M.D., +351 210 405 907, andre.mansinho@startlisbon.com
Andre Mansinho, M.D.
Spain1 site, 1 recruiting
- Recruiting
Clinica Mi Nova Alianca
Lleida, 25004
Santiago Viteri, M.D., Ph.D., + 34 932287445, santiago.viteri@pratia.com
Santiago Viteri, M.D.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Jeffrey Yachnin, +46812370000, jeffrey.yachnin@regionstockholm.se
Jeffrey Yachnin
About this study
Official title: 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
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.
Read the 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 and is conducted in 3 parts. The study 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).
Part A, which is now closed, used an intra patient dose escalation design to evaluate safety across multiple dose levels.
The study is currently in Part B, an exposure based dose escalation phase. Patients may be enrolled into either a 24 hour or a 72 hour exposure cohort. Exposure duration is defined by the timing of hemodialysis, as elimination of orellanine occurs primarily through dialysis initiated after infusion. The starting dose for Part B is 0.38 mg/kg, and the total dose per treatment cycle is limited to 2.5 mg/kg, including any replacement doses. A minimum of three patients will be enrolled in each cohort, and escalation to longer exposure durations occurs only after safety evaluation.
Part C is a planned dose expansion phase to further characterize safety and explore preliminary antitumor activity at the selected dose and exposure level.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Orellanine
- Keywords
- Renal cancer, Kidney cancer, Metastatic, Dialysis, Hemodialysis, Clear-cell renal cell carcinoma (ccRCC), Metastatic renal cell carcinoma (mRCC), Papillary renal cell carcinoma (pRCC), End stage Kidney Disease, Advanced renal cell carcinoma, Investigational drug kidney cancer, ONC175, Oncorena
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasm Metastasis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrellanineDrug
Orellanine administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part B - 24-Hour Exposure Cohort | Experimental | Participants receive orellanine (ONC175) as a 30 minute intravenous infusion once during each 28 day treatment cycle. Hemodialysis is performed the day before the infusion and again approximately 24 hours after the infusion to define the exposure period, as orellanine is eliminated primarily through dialysis. Participants will continue their regular hemodialysis schedule throughout the cycle. Receives: Drug: Orellanine |
| Part B - 72 Hour Exposure Cohort | Experimental | Participants receive orellanine (ONC175) as a 30 minute intravenous infusion once during each 28 day treatment cycle. In this cohort, hemodialysis is performed on the morning of the infusion, and additional hemodialysis sessions occur on the following days. Replacement doses of orellanine may be administered on the days after the initial infusion, depending on the assigned dose level. Hemodialysis is performed approximately 72 hours after the initial infusion to define the extended exposure period, as orellanine is eliminated primarily through dialysis. Receives: Drug: Orellanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0.
Measured: Through study completion, approximately 1 year
Changes in arterial blood pressure measurements
Measured: Through study completion, approximately 1 year
Changes in pulse rate measurements
Measured: Through study completion, approximately 1 year
Changes in respiratory rate measurements
Measured: Through study completion, approximately 1 year
Changes in temperature measurements
Measured: Through study completion, approximately 1 year
Changes in physical examination findings
Measured: Through study completion, approximately 1 year
Maximum tolerable dose of orellanine
Measured: Through study completion, approximately 1 year
Secondary outcomes (10)
Efficacy of orellanine based on time to tumor response
Measured: Through study completion, approximately 1 year.
Efficacy of orellanine based on best overall response
Measured: Through study completion, approximately 1 year.
Area under the curve extrapolated to infinity
Measured: Through study completion, approximately 1 year.
Terminal half-life
Measured: Through study completion, approximately 1 year.
Partial area under the curve
Measured: Through study completion, approximately 1 year.
Dose proportionality
Measured: Through study completion, approximately 1 year.
Time to maximum plasma concentration
Measured: Through study completion, approximately 1 year.
Maximum plasma concentration
Measured: Through study completion, approximately 1 year.
Total body clearance
Measured: Through study completion, approximately 1 year.
Volume of distribution
Measured: Through study completion, approximately 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start4 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncorena AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287945
- Sponsor's protocol ID
- ONC001-CL-001
- Status last verified
- Sep 2026
- First submitted
- 24 May 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pursuant to relevant data protection and privacy legislation, patients will authorize the collection, use and disclosure of their study data by the investigator and by those persons who need that information for the purposes of the study.
Publications
Buvall L, Hedman H, Khramova A, Najar D, Bergwall L, Ebefors K, Sihlbom C, Lundstam S, Herrmann A, Wallentin H, Roos E, Nilsson UA, Johansson M, Tornell J, Haraldsson B, Nystrom J. Orellanine specifically targets renal clear cell carcinoma. Oncotarget. 2017 Jul 25;8(53):91085-91098. doi: 10.18632/oncotarget.19555. eCollection 2017 Oct 31.
PubMed 29207627Dy GW, Gore JL, Forouzanfar MH, Naghavi M, Fitzmaurice C. Global Burden of Urologic Cancers, 1990-2013. Eur Urol. 2017 Mar;71(3):437-446. doi: 10.1016/j.eururo.2016.10.008. Epub 2016 Oct 28.
PubMed 28029399Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774Hedman H, Holmdahl J, Molne J, Ebefors K, Haraldsson B, Nystrom J. Long-term clinical outcome for patients poisoned by the fungal nephrotoxin orellanine. BMC Nephrol. 2017 Apr 3;18(1):121. doi: 10.1186/s12882-017-0533-6.
PubMed 28372584Merza H, Bilusic M. Current Management Strategy for Metastatic Renal Cell Carcinoma and Future Directions. Curr Oncol Rep. 2017 Apr;19(4):27. doi: 10.1007/s11912-017-0583-8.
PubMed 28303494Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
PubMed 7165009Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05287945
- Acronym / sponsor ID
- ONC001-CL-001
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Renal cancer, Kidney cancer, Metastatic, Dialysis, Hemodialysis, Clear-cell renal cell carcinoma (ccRCC), Metastatic renal cell carcinoma (mRCC), Papillary renal cell carcinoma (pRCC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Oncorena ABIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 and is conducted in 3 parts. The study 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).
Part A, which is now closed, used an intra patient dose escalation design to evaluate safety across multiple dose levels.
The study is currently in Part B, an exposure based dose escalation phase. Patients may be enrolled into either a 24 hour or a 72 hour exposure cohort. Exposure duration is defined by the timing of hemodialysis, as elimination of orellanine occurs primarily through dialysis initiated after infusion. The starting dose for Part B is 0.38 mg/kg, and the total dose per treatment cycle is limited to 2.5 mg/kg, including any replacement doses. A minimum of three patients will be enrolled in each cohort, and escalation to longer exposure durations occurs only after safety evaluation.
Part C is a planned dose expansion phase to further characterize safety and explore preliminary antitumor activity at the selected dose and exposure level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part B - 24-Hour Exposure Cohort | Experimental | Drug: OrellanineParticipants receive orellanine (ONC175) as a 30 minute intravenous infusion once during each 28 day treatment cycle. Hemodialysis is performed the day before the infusion and again approximately 24 hours after the infusion to define the exposure period, as orellanine is eliminated primarily through dialysis. Participants will continue their regular hemodialysis schedule throughout the cycle. |
| Part B - 72 Hour Exposure Cohort | Experimental | Drug: OrellanineParticipants receive orellanine (ONC175) as a 30 minute intravenous infusion once during each 28 day treatment cycle. In this cohort, hemodialysis is performed on the morning of the infusion, and additional hemodialysis sessions occur on the following days. Replacement doses of orellanine may be administered on the days after the initial infusion, depending on the assigned dose level. Hemodialysis is performed approximately 72 hours after the initial infusion to define the extended exposure period, as orellanine is eliminated primarily through dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Has provided written informed consent.
- Has a diagnosis of histologically confirmed advanced ccRCC or pRCC. No conventional therapy is available or considered appropriate by the treating physician or is declined by the patient.
- For patients in the expansion portion of the study only: Measurable disease per RECIST version 1.1 criteria.
- ECOG performance status of 0 - 2.
- Age ≥18 years.
Key exclusion criteria (9 listed)
- Diagnosis of any other malignancy within 2 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, superficial melanoma, or carcinoma in situ of the breast or of the cervix, or low grade (Gleason 7 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g., surgery, radiation, or castration)
- Radiotherapy within 2 weeks before first dose.
- Immuno-oncology therapy (IO) given in the last six (6) months prior to enrolment
- Other systemic anti-cancer therapy within 2 weeks before first dose.
- Has not recovered from AEs due to prior anti-cancer medications to at least grade 1 by CTCAE version 5.0 (except for alopecia and grade 2 neuropathy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrellanineOrellanine administered intravenously | Drug | Part B - 24-Hour Exposure Cohort, Part B - 72 Hour Exposure Cohort |
Primary outcome
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0.
Time frame: Through study completion, approximately 1 year
Changes in arterial blood pressure measurements
Time frame: Through study completion, approximately 1 year
Changes in pulse rate measurements
Time frame: Through study completion, approximately 1 year
Changes in respiratory rate measurements
Time frame: Through study completion, approximately 1 year
Changes in temperature measurements
Time frame: Through study completion, approximately 1 year
Changes in physical examination findings
Time frame: Through study completion, approximately 1 year
Maximum tolerable dose of orellanine
Time frame: Through study completion, approximately 1 year
10 secondary outcomes
Efficacy of orellanine based on time to tumor response
Time frame: Through study completion, approximately 1 year.
Efficacy of orellanine based on best overall response
Time frame: Through study completion, approximately 1 year.
Area under the curve extrapolated to infinity
Time frame: Through study completion, approximately 1 year.
Terminal half-life
Time frame: Through study completion, approximately 1 year.
Partial area under the curve
Time frame: Through study completion, approximately 1 year.
Dose proportionality
Time frame: Through study completion, approximately 1 year.
Time to maximum plasma concentration
Time frame: Through study completion, approximately 1 year.
Maximum plasma concentration
Time frame: Through study completion, approximately 1 year.
Total body clearance
Time frame: Through study completion, approximately 1 year.
Volume of distribution
Time frame: Through study completion, approximately 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 29207627Buvall L, Hedman H, Khramova A, Najar D, Bergwall L, Ebefors K, Sihlbom C, Lundstam S, Herrmann A, Wallentin H, Roos E, Nilsson UA, Johansson M, Tornell J, Haraldsson B, Nystrom J. Orellanine specifically targets renal clear cell carcinoma. Oncotarget. 2017 Jul 25;8(53):91085-91098. doi: 10.18632/oncotarget.19555. eCollection 2017 Oct 31.
- Background: PubMed 28029399Dy GW, Gore JL, Forouzanfar MH, Naghavi M, Fitzmaurice C. Global Burden of Urologic Cancers, 1990-2013. Eur Urol. 2017 Mar;71(3):437-446. doi: 10.1016/j.eururo.2016.10.008. Epub 2016 Oct 28.
- Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
- Background: PubMed 28372584Hedman H, Holmdahl J, Molne J, Ebefors K, Haraldsson B, Nystrom J. Long-term clinical outcome for patients poisoned by the fungal nephrotoxin orellanine. BMC Nephrol. 2017 Apr 3;18(1):121. doi: 10.1186/s12882-017-0533-6.
- Background: PubMed 28303494Merza H, Bilusic M. Current Management Strategy for Metastatic Renal Cell Carcinoma and Future Directions. Curr Oncol Rep. 2017 Apr;19(4):27. doi: 10.1007/s11912-017-0583-8.
- Background: PubMed 7165009Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
- Background: PubMed 29313949Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
- Individual participant dataSharing planned: No. Pursuant to relevant data protection and privacy legislation, patients will authorize the collection, use and disclosure of their study data by the investigator and by those persons who need that information for the purposes of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oncorena Study General Inquiries contact
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Orellanine in people with Carcinoma, Renal Cell, run by Oncorena AB at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, France, Portugal, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanjing Xie, Ph.D. (+46737031615, hanjing.xie@oncorena.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0. (time frame: Through study completion, approximately 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287945, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.