Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2024-02-07
• Target enrollment: 0
• Participant gender: All

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. The study will include an intra-patient dose escalation phase, followed by a dose expansion phase.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theradex

Criteria

Inclusion Criteria:

• Provided written informed consent.

• Diagnosis of histologically confirmed advanced ccRCC or pRCC with progression or intolerance to all standard therapies for which the patient is eligible. There is no limit to the number of prior treatments.

• Measurable disease per RECIST version 1.1 criteria.

• ECOG performance status of 0 - 2.

• Age ≥18 years.

• Life expectancy ≥3 months.

• Acceptable hematologic laboratory values defined as:

1. Neutrophils ≥1.5 × 10^9/L, without growth factor stimulation within 3 weeks prior to the blood test;

2. Platelets ≥100 × 10^9/L;

3. Haemoglobin ≥5.9 mmol/L (~9.5 g/dL), without transfusion within 4 weeks prior to the blood test. Use of erythropoietic is permitted.

• Must be on chronic haemodialysis (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 patients' 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.

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).

• Has symptomatic, steroid-dependent, or progressive brain metastasis / metastases. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during trial screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of trial treatment.

• Radiotherapy within 4 weeks before first dose.

• Systemic anti-cancer therapy within 4 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 (IP) 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.