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.
FOR FURTHER INFORMATION
If you are interested in understanding in participating in this clinical trial, please ask your referring doctor/oncologist to contact firstname.lastname@example.org.