NCT05755113

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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: QBiotics Group Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Tigilanol Tiglate	Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.

Timeline

• Start date: 2023-04-13
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2023-03-06
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study