ZU545102: An open-label, multi-centre Phase Ib study of the safety and tolerability of IV infused PG545 in combination with nivolumab (Opdivo®) in patients with advanced solid tumours with an expansion cohort in patients with metastatic pancreatic cancer
Stage 1 - Dose escalation in patients with solid tumors (multiple indications)
Stage 2 - Dose expansion in patients with mPDAC (30 subjects)
Combination: Pixatimod and Nivolumab
Determine the maximum tolerable dose of the combination and safety and tolerability of combination at the recommended dosage in expansion cohort.
Anti-tumor activity using RECIST v1.1 and immune-related response criteria (irRC)
Pharmacodynamics by analysing biomarkers of immunomodulation in the peripheral blood
Escalation phase completed November 2018.
Pixatimod and Nivolumab tolerable with a safety profile similar to other immunotherapy combinations.
4 out of 5 MSS CRC patients (80%) showed clinical benefit and 2 patients had tumor reductions.
PD data consistent with innate and adaptive immune cell activation
Enrollment in expansion cohort underway.
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