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.
QBiotics Group Limited
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.
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 tumou…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Onco…
Interventions
- DrugTigilanol Tiglate
Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.
Location
- Memorial Sloan Kettering Cancer CentreNew York, New York