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A Phase I study of the novel immunomodulatory agent PG545 (pixatimod) in subjects with advanced solid tumours

Keith Dredge1, Todd V Brennan2, Edward Hammond3

  • 1Zucero Therapeutics, Brisbane, QLD, Australia. keith.dredge@zucero.com.au.

British Journal of Cancer
|March 14, 2018
PubMed
Abstract

Insights

Pixatimod (PG545) shows a tolerable safety profile and stimulates innate immune responses in patients with advanced solid tumors. Further research is warranted for combination therapies.

Area of Science:

  • Immunology
  • Pharmacology
  • Oncology

Background:

  • Pixatimod (PG545) is a novel immunomodulatory agent.
  • Preclinical models show PG545 stimulates innate immune responses against tumors.

Purpose of the Study:

  • Investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PG545 monotherapy in patients with advanced solid malignancies.

Main Methods:

  • Phase I study with escalating doses of PG545 (25, 50, 100, 150 mg) administered as weekly intravenous infusions.
  • Twenty-three subjects were enrolled across four dose cohorts.
  • Safety, tolerability, PK/PD, and preliminary efficacy were assessed.

Main Results:

  • Maximum-tolerated dose identified as 100 mg; dose-limiting toxicities (hypertension, epistaxis) occurred at 150 mg.
  • 38% disease control rate observed; best response was stable disease up to 24 weeks.
  • Pharmacodynamic data showed increased innate immune cell activation and elevated plasma cytokines (IFNγ, TNFα, IP-10, MCP-1).

Conclusions:

  • PG545 demonstrates a tolerable safety profile, proportional pharmacokinetics, and evidence of immune cell stimulation.
  • Disease control was observed in some subjects, supporting its mechanism of action.
  • PG545 represents a promising approach for combination therapy in cancer treatment.

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