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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumour Response
Secondary outcome measures
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Systemic Exposure
Other outcome measures
Evaluation of Peripheral Blood Mononucleocytes (PBMCs)
Local Recurrence Rate at injection site(s)
Tumour Microenvironment
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being welcomed into this experiment?
"As per the clinicaltrials.gov website, this clinical trial is not presently enrolling individuals into its program. The initial posting was on March 13th 2023 and the last edit occurred on March 2nd 2023. Nevertheless, there are currently 445 other trials searching for participants right now."
Answered by AI
Has the Single Arm, Open Label protocol been validated by the FDA?
"As a Phase 2 trial, Single Arm Open Label has some safety data associated with it and thus received an estimated score of 2."
Answered by AI
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