Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma (NCT05287945) | Clinical Trial Compass
RecruitingPhase 1/2
Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma
United States, Portugal, Sweden75 participantsStarted 2023-08-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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;
Exclusion criteria
✕. 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.
What they're measuring
1
Adverse events and laboratory abnormalities as graded by NCI CTCAE v5.0.
Timeframe: Through study completion, approximately 1 year
2
Changes in arterial blood pressure measurements
Timeframe: Through study completion, approximately 1 year
3
Changes in pulse rate measurements
Timeframe: Through study completion, approximately 1 year
4
Changes in respiratory rate measurements
Timeframe: Through study completion, approximately 1 year
5
Changes in temperature measurements
Timeframe: Through study completion, approximately 1 year
6
Changes in physical examination findings
Timeframe: Through study completion, approximately 1 year
7
Maximum tolerable dose of orellanine
Timeframe: Through study completion, approximately 1 year
✕. 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.
✕. 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.