Actively Recruiting
A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
Led by QBiotics Group Limited · Updated on 2026-03-12
40
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with study requirements
- At least 18 years old at the time of consent
- Have advanced or metastatic soft tissue sarcoma of the body wall, extremities, or scalp confirmed by pathology
- Tumor suitable for injection by palpation or ultrasound guidance
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Life expectancy greater than 12 weeks
- Adequate kidney and liver function as determined by the Investigator
- Women of child-bearing potential must have a negative pregnancy test within 14 days before first study drug, use effective contraception during and 30 days after study, and not breastfeed
- Men with fertile female partners must have had vasectomy or use contraception during and 30 days after study, and not donate sperm during this period
You will not qualify if you...
- Planning to receive intratumoural treatment or radiotherapy to tumors intended for injection within 28 days before or during treatment
- Tumor next to or infiltrating any major artery or vein making injection unsafe
- Receiving or recently received other investigational agents or devices without a 28-day washout and full recovery from side effects
- Receiving or recently received systemic anticancer therapy without 28-day washout and full recovery; patients with mild neuropathy may be eligible after discussion
- Major surgery within 28 days before first treatment or expected during study; minor surgery allowed with healing time
- Active brain metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Any bleeding disorder or on therapeutic warfarin making injection or biopsy unsafe
- History of severe allergic reactions to tigilanol tiglate or similar compounds
- Investigator judges participant inappropriate due to psychiatric or substance abuse conditions that interfere with study cooperation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Centre
New York, New York, United States, 10065
Actively Recruiting
Research Team
H
Head of Human Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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