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Virus Therapy
Intratumoral Tigilanol Tiglate for Soft Tissue Sarcoma
Phase 2
Recruiting
Led By Edmund Bartlett, MD
Research Sponsored by QBiotics Group Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug to treat a type of cancer in the arms, legs, and body wall.
Who is the study for?
Adults with advanced soft tissue sarcoma in limbs or body wall, able to consent and follow study rules. They must have a life expectancy over 12 weeks, be relatively active (ECOG ≤ 2), and not pregnant or breastfeeding. Participants need functioning kidneys and liver, agree to use contraception, and can't have major blood vessel tumors or recent treatments that conflict with the trial.
What is being tested?
The trial is testing Tigilanol Tiglate's effectiveness when injected directly into tumors of patients with advanced soft tissue sarcomas. It's an open-label Phase IIa study meaning everyone gets the treatment and both doctors and participants know what's being given.
What are the potential side effects?
Specific side effects are not listed but may include typical reactions at injection sites such as pain, swelling, possible inflammation around the tumor area due to direct injection of medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tumour Response
Secondary study objectives
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Systemic Exposure
Other study objectives
Evaluation of Peripheral Blood Mononucleocytes (PBMCs)
Local Recurrence Rate at injection site(s)
Tumour Microenvironment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm, Open LabelExperimental Treatment1 Intervention
Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area \[BSA\]) per treatment.
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Who is running the clinical trial?
QBiotics Group LimitedLead Sponsor
3 Previous Clinical Trials
41 Total Patients Enrolled
Edmund Bartlett, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to have direct tumor treatment or radiation within 28 days before screening or while on tigilanol tiglate.My tumor is near or has spread into a major blood vessel.I can take care of myself and am up and about more than half of my waking hours.I haven't had major surgery in the last 28 days and don't expect to need any during the study.I have no severe allergies to tigilanol tiglate or similar compounds.I do not have any bleeding disorders that make injections or biopsies unsafe, and I am not on warfarin.I am 18 years old or older.My cancer is on the body wall or limbs and can be injected directly.I haven't used any experimental drugs or devices recently, or it's been long enough since I last did.My kidney and liver functions are within normal ranges.I am not pregnant, will use effective birth control, and am not breastfeeding.I've had cancer treatment recently but have recovered from side effects.I am a man who will not father a child or donate sperm during and up to 30 days after the study.I have treated brain metastases and am neurologically stable.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm, Open Label
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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