Spots Global Cancer Trial Database for A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
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Trial Identification
Brief Title: A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
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.
Study ID: NCT05755113
Conditions
Interventions
Study Description
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. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Centre, New York, New York, United States
Contact Details
Name: Edmund Bartlett, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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