Soft Tissue Sarcoma Clinical Trial
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.
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.
Primary Objective 1. To evaluate tumour ablation in tumours and/or tumour segments following one or more treatments with tigilanol tiglate. 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; 2. To evaluate the degree of immune response elicited with intratumoural tigilanol tiglate; 3. To evaluate local recurrence rate. ;
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