A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. Are willing and able to provide written informed consent for the study prior to any protocol-specific procedures and to comply with all local and study requirements. 2. Are ≥ 18 years of age on the day of providing informed consent. 3. Have advanced and/or metastatic disease of the body wall or extremities that is amenable to intratumoural injection either by palpation or under ultrasound guided injection, that has been histologically or pathologically confirmed as an STS. STS located on the scalp may also be considered for treatment. 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 5. Have life expectancy of more than 12 weeks. 6. Have adequate renal and hepatic function as assessed by the Investigator. 7. Female participants who are Women Of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test at Screening (within 14 days of the first study drug administration), must be willing to use a highly effective contra