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

Qualifiers

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.