COMPLETED TRIALS


PG545101: An open-label, single centre Phase 1 study of the safety and tolerability of PG545 in patients with advanced solid tumors

Type of trial: Monotherapy

Indication: Various solid tumors

Study rationale:

Primary Objective

Identify maximum tolerated dose of PG545 when administered once weekly via subcutaneous (SC) injection.

Secondary Objectives

  • Anti-tumor activity using RECIST v1.1.

  • Evaluating the safety and tolerability

  • Pharmacokinetics and pharmacodynamics by analysing biomarkers.

Outcomes:

Study demonstrated that subcutaneous injection administration was not tolerated due to local injection site reactions.


PG545102: An open-label, multi-centre Phase I study of the safety and tolerability of IV infused PG545 in patients with advanced solid tumors

Type of trial: Monotherapy

Indication: Various solid tumours

Study rationale:

Primary objective

Identify maximum tolerated dose of PG545 when administered once weekly via intravenous infusion.

Secondary objective

  • Anti-tumor activity using RECIST v1.1.

  • Evaluating safety and tolerability

  • Pharmacokinetics and pharmacodynamics by analysing biomarkers

Outcomes:

  • Maximum tolerated dosage (MTD) of 100mg

  • Disease control rate was 38%, median duration of SD was 57 days, a CRC patient had SD for 16 weeks

  • Post-treatment activation of DC and NK cells was observed.