A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
brief summary
A Phase IIa open label study evaluating the preliminary efficacy of intratumoural tigilanol tiglate in advanced and/or metastatic soft tissue sarcoma of the extremities and body wall.
detailed 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; 4. To evaluate Progression Free Survival (PFS) (Stage 2 only); and 5. To evaluate metabolites after a single intratumoural injection of tigilanol tiglate (Stage 2 only).
official title
A Phase IIa Open Label Study Evaluating the Preliminary Efficacy of Intratumoural Tigilanol Tiglate in Advanced and/or Metastatic Soft Tissue Sarcoma of the Extremities and Body Wall.