Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area \[BSA\]) per treatment.

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

Tigilanol Tiglate

Head of Human Clinical Operations

Edmund Bartlett

Edmund Bartlett, MD

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.

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.

To assess changes in the tumour microenvironment by looking at the change from baseline of immune cell infiltration in tumour biopsy tissue collected after injection with tigilanol tiglate.

Evaluation of Peripheral Blood Mononucleocytes (PBMCs).

Percentage of participants with local recurrence at injection site(s) at 6-months after first treatment.

Proportion of participants who have achieved partial or complete ablation of treated tumour(s) and/or tumour segment(s) following injection(s) with tigilanol tiglate.

Total number of Adverse Events (AEs) and Serious Adverse Events (SAEs) and number of AEs and SAEs deemed related to tigilanol tiglate.

Evaluation of how much tigilanol tiglate is circulating in the blood after a single injection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma	NCT05755113	Soft Tissue Sar...	Tigilanol Tigla...	18 Years -	QBiotics Group Limited
A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma	NCT05755113	Soft Tissue Sar...	Tigilanol Tigla...	18 Years -	QBiotics Group Limited

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Spots Global Cancer Trial Database for extremeties

Every month we try and update this database with for extremeties cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for extremeties cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.