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Clinical study investigating the safety PG545 in combination with nivolumab in patients with advanced solid tumours and in patients with metastatic pancreatic cancer

ABSTRACT: Interventions: Stage 1: Dose escalation in patients with advanced or metastatic solid tumours: PG545 25, 50 or 100 mg once weekly via IV infusion and Nivolumab 240 mg every two weeks via IV infusion. Patients receive weekly doses of PG545 according to the cohort to which they are assigned. A standard 3+3 cohort design is employed for each cohort. Intrasubject escalation to the next highest dose is allowed once the next highest dose has been demonstrated to be tolerated. Stage 2: Expansion phase in patients with metastatic pancreas tumour or MSS mCRC: Recommended PG545 dose from Stage 1 once weekly via IV infusion and Nivolumab 240 mg every two weeks via IV infusion. Treatment to continue until disease progression or withdrawal due to tolerability. Patients will be treated at site ensuring treatment compliance. Primary outcome(s): Stage 1: Determine the maximum tolerated dose (MTD) of once-weekly intravenously administered PG545 in combination with intravenously administered nivolumab (240 mg every two weeks) in subjects with advanced solid tumours, as defined by dose limiting toxicity. The MTD is determined using dose limiting toxicities (DLTs) assessed by the treating physician, using NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. DLT toxicities also include the development of positive anti-heparin antibody, and an inability to complete the first dosing cycle due to any toxicity thought to be associated with the test drug.[28 days post treatment commencement.];Stage 2: To assess the safety and tolerability of weekly administration of PG545 in combination with nivolumab in patients with metastatic pancreatic cancer. Outcome is assessed by clinical examination and blood tests.[Weekly for the duration of the study.] Study Design: Purpose: Treatment; Allocation: Non-randomised trial

DISEASE(S): Cancer-pancreatic,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Pancreatic Cancer,Advanced Solid Tumours

PROVIDER: 2466336 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Clinical study investigating the safety PG545 in combination with nivolumab in patients with advanced solid tumours and in patients with metastatic pancreatic cancer

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