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Investigating the safety and tolerability of PMR-116 in Patients with Advanced Malignancies
Pimera Australia Pty Ltd
This trial will be conducted across two parts. In the first part (Dose Escalation), participants will receive multiple doses of PMR-116 (administered orally), to be taken at set times throughout a 28-day treatment cycle. If this appears safe, additional participants in a second cohort will receive an increased dose of PMR-116 to be taken at set times throughout a 28-day cycle. Up to 5 increasing doses will be investigated in separate treatment cohorts until the maximum safe dose has been determined. In the second part of the study (Dose Expansion), a new cohort of participants will receive multiple doses of the maximum safe dose of PMR-116 to be taken at set times throughout a 28-day cycle. Participants in each part of the study will be asked to provide a sample of their tumour (taken via a biopsy) prior to starting PMR-116, and those in the second part will also be asked to provide a sample after 22 days after starting treatment. It is hoped this research will determine the maximum dose of PMR-116 that can be administered safely without causing severe reactions. Once the dose of PMR-116 has been determined, a larger trial investigating the efficacy of PMR-116 as a treatment for cancer patients with advanced solid tumours may proceed.