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

Study Rationale:

Primary Objective

Determine the maximum tolerable dose of the combination and safety and tolerability of combination at the recommended dosage in expansion cohort.

Secondary Objectives

  • 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.


If you are interested in understanding in participating in this clinical trial, please ask your referring doctor/oncologist to contact