Actively Recruiting
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
Led by QBiotics Group Limited · Updated on 2026-03-12
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary effectiveness of intratumoural tigilanol tiglate in patients with advanced or metastatic soft tissue sarcoma located in the extremities and body wall. This Phase IIa open-label study aims to assess tumour destruction following one or more treatments and the overall disease control beyond injected tumours. Additional goals include assessing safety, tolerability, systemic exposure, immune response, and progression-free survival in certain stages of the study. Participants will receive one or multiple injections of tigilanol tiglate directly into their tumours at a dose up to 3.6 mg/m2 based on body surface area. The treatment is administered intratumourally and may be guided by palpation or ultrasound. The study is open label with a single treatment arm, and the effects of the drug on injected and sometimes non-injected tumours will be monitored over time. Throughout the study, participants will undergo various assessments including tumour response evaluations at 3 and 6 months after initial treatment. Researchers will monitor adverse events for safety up to 6 months and perform pharmacokinetic testing after the first dose. Additional exploratory assessments include tumour microenvironment analysis, immune response, local recurrence rates, and metabolic profiling. Overall, participant involvement includes treatment, follow-up visits, safety monitoring, and outcome measurements lasting at least 6 months.
CONDITIONS
Brief 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
- 18 years of age or older at consent
- Have advanced and/or metastatic soft tissue sarcoma of the body wall, extremities, or scalp confirmed by pathology and suitable for intratumoural injection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than 12 weeks
- Adequate kidney and liver function as assessed by the investigator
- Women of childbearing potential must have a negative pregnancy test, agree to use effective contraception during the study and for 30 days after, and not be breastfeeding
- Male participants with fertile partners must have had vasectomy or agree to use contraception during the study and for 30 days after, and must not donate sperm during this period
You will not qualify if you...
- Planning intratumoural treatment or radiotherapy to tumors intended for injection within 28 days before screening or during treatment
- Tumor located immediately next to or invading major arteries or veins
- Use of other investigational agents or devices without a 28-day washout prior to first tigilanol tiglate treatment
- Use of systemic anticancer therapy without a 28-day washout before treatment; Grade 2 or less neuropathy may be considered
- Major surgery within 28 days before treatment or planned during the study (minor surgery allowed with healing time)
- Active brain metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Bleeding disorders or on therapeutic warfarin making injection unsafe
- History of severe allergic reaction to tigilanol tiglate or similar compounds
- Any condition or disorder that, in the investigator's opinion, makes the participant unsuitable for the study, including psychiatric or substance abuse issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive one or more intratumoral injections of tigilanol tiglate for tumor ablation and disease control.
Multiple visits for treatment and safety assessments during this period
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
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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