A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma

Description

Primary Objective

1. To evaluate tumour ablation in tumours and/or tumour segments following one or more treatments with tigilanol tiglate; and
2. To evaluate the effect of tigilanol tiglate on overall disease control (not limited to injected tumours) (Stage 2 only).

Secondary Objective

1. To assess the safety and tolerability of intratumoural injections with tigilanol tiglate; and
2. To evaluate systemic exposure through pharmacokinetic (PK) assessment after a single intratumoural injection of tigilanol tiglate.

Exploratory Objectives

1. To evaluate the microenvironment of injected tumours +/- non-injected tumours;
2. To evaluate the degree of immune response elicited with intratumoural tigilanol tiglate;
3. To evaluate local recurrence rate; and
4. To evaluate metabolites after a single intratumoural injection of tigilanol tiglate (Stage 2 only).