Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
ConditionCarcinoma, Renal Cell
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncorena AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Orellanine
DrugOrellanine administered intravenously
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Part B - 24-Hour Exposure CohortExperimental treatment 1 intervention
Group B: Part B - 72 Hour Exposure CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0.
Time frame
Through study completion, approximately 1 year2
Changes in arterial blood pressure measurements
Time frame
Through study completion, approximately 1 year3
Changes in pulse rate measurements
Time frame
Through study completion, approximately 1 year4
Changes in respiratory rate measurements
Time frame
Through study completion, approximately 1 yearSecondary outcomes
1
Efficacy of orellanine based on time to tumor response
Time frame
Through study completion, approximately 1 year.2
Efficacy of orellanine based on best overall response
Time frame
Through study completion, approximately 1 year.3
Area under the curve extrapolated to infinity
Time frame
Through study completion, approximately 1 year.4
Terminal half-life
Time frame
Through study completion, approximately 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov