Phase IIa Study of Intratumoral Tigilanol Tiglate for Advanced or Metastatic Soft Tissue Sarcoma of the Body Wall and Extremities

What this Trial Is About

Researchers are evaluating the preliminary effectiveness of intratumoural tigilanol tiglate in patients with advanced or metastatic soft tissue sarcoma located in the extremities and body wall. This Phase IIa open-label study aims to assess tumour destruction following one or more treatments and the overall disease control beyond injected tumours. Additional goals include assessing safety, tolerability, systemic exposure, immune response, and progression-free survival in certain stages of the study. Participants will receive one or multiple injections of tigilanol tiglate directly into their tumours at a dose up to 3.6 mgm2 based on body surface area. The treatment is administered intratumourally and may be guided by palpation or ultrasound. The study is open label with a single treatment arm, and the effects of the drug on injected and sometimes non-injected tumours will be monitored over time. Throughout the study, participants will undergo various assessments including tumour response evaluations at 3 and 6 months after initial treatment. Researchers will monitor adverse events for safety up to 6 months and perform pharmacokinetic testing after the first dose. Additional exploratory assessments include tumour microenvironment analysis, immune response, local recurrence rates, and metabolic profiling. Overall, participant involvement includes treatment, follow-up visits, safety monitoring, and outcome measurements lasting at least 6 months.

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