A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
Part of paid clinical trials in New York, New York.
- Sponsor
- QBiotics Group Limited
- Study ID
- NCT05755113
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Soft Tissue Sarcoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tigilanol Tiglate — DRUGTigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.
Study Details
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.
Key Dates
- Start date
- Apr 13, 2023
- Status verified
- Feb 2026
- Primary completion
- Jan 31, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single Arm, Open LabelSingle or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area \[BSA\]) per treatment.
Primary Outcome Measure
Tumour Response [ Time Frame: 6 months ]
Central Contacts
- Head of Human Clinical Operations+61 (0) 738 708 933
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Centre | New York | New York | 10065 | Edmund Bartlett (PRINCIPAL_INVESTIGATOR) |
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